How to Document Risk in your 510(k)

You can document Risk in a 510(k) by comparing subject device with one or more similar legally marketed devices to support substantial equivalency claims. To legally market your medical device, you need to demonstrate it is as safe and effective as any other legally marketed product that is not subject to PMA (21 CFR 807.92(a)(3)).

The blog describes key factors for documenting risk management in 510(k) submissions. Here is a list of questions we should understand:

  • What is a predicate device and how to claim substantial equivalence to a proposed device?
  • Types of devices needing risk management for 510(k) submissions?
  • Risk management requirements for a Traditional 510(k)?
  • Where can one find 510(k) risk management requirements?
  • How can manufacturers demonstrate device safety?
  • Key factors for documenting risks before submitting 510(k)?
  • Contents of software related documentation?
  • What are the contents of risk related documentation?


Using Substantial equivalence to demonstrate risk management in the 510(k) submission. 

A predicate device is a legally marketed device subjected to premarket approval. We can demonstrate Substantial Equivalence by comparing the applicant’s device to a cleared predicate device, if:

  • it was cleared through the 510(k) process
  • it was legally marketed prior to May 28, 1976 (pre-amendments device)
  • it was originally on the U.S. market as a Class III device (Premarket approval) and later down-classified to Class II or I
  • it is a 510(k)-exempt device

We can demonstrate substantial equivalence if predicate device has:

  • The same intended use as the predicate; and
    • the same technological characteristics as the predicate
  • The same intended use as the predicate; and
    • different technological characteristics and the information submitted to FDA and
    • does not raise new questions of safety and effectiveness; and
    • demonstrates that the device is at least as safe and effective as the legally marketed device.
  • Same technical characteristics can be:
    • The design
    • Energy used or delivered
    • Materials of construction
    • Performance
    • Safety
    • Effectiveness
    • Labeling
    • Biocompatibility
    • Environmental conditions
    • Storage/ transport
    • operating

If the new device has some different technological characteristics the differences must not raise questions of safety or effectiveness when you’re testing the device as safe and effective as the predicate device. However, if testing is done in accordance with FDA recognized standard then certificate of compliance to that standard is sufficient for the submission, and global test information or test data is not required.

A simple way to show substantial equivalence is to create a comparison table including: 

  • Technological specifications mentioned below:
    • Intended use, Indications for use
    • Target population, Anatomical sites, where used (hospital, home, etc.)
    • Energy used and/or delivered
    • Human factors, Design, Performance, Standards met, Materials, Biocompatibility, Compatibility with environment and other devices
    • Sterility, Electrical safety, Mechanical safety, Chemical safety, Thermal safety, Radiation safety
  • A Narrative discussing similarities and differences between new and predicate device


Devices requiring risk management for 510(k) submission.

  • Risk management requirements are only for devices that contain software.
  • Abbreviated 510(k)s generally require declarations of conformity and risk management documents


Risk management requirements for a Traditional 510(k). 

Only embedded software, driven by or standalone software and devices with software component must include Hazard Identification and Risk Assessment in 510(k)s.

When there is insufficient information to create general controls, special controls provide reasonable assurance of safety and effectiveness. It assures FDA that hazards related to device development process were subject to controls and mitigations.

You should include Risk Control Verification and Validation requirements under

  • Packaging Validation
    • Sterilization Validation
    • Biocompatibility
    • Software Verification Validation
    • Electrical Safety and EMC
    • Bench/Pre-Clinical Performance Testing
    • Animal Performance Testing
    • Clinical Performance Testing

Risks to Users and Patients are addressed in the Instructions for Use (IFU) as warnings, contraindications, and precautions (typically because of usability studies and hazard analysis).

Risk-Benefit Analysis is required in Special 510(k)s, De Novo applications, Humanitarian Device Exemptions, and PMAs. It is not required for traditional 510(k).

Where can one find 510(k) risk management requirements?

Design validation-software validation and risk analysis (21 CFR 820.30) FDA and EU CE Marking compliance- recognize ISO 14971 standard:

  • FDA recognizes ISO 14971:2019
  • EU recognizes EN ISO 14971:2019 (differences include omission of Annexes, decoupling of standards to MDR regs),

Best practices to address risks in 510(k) submissions

  • Look for appropriate Special Controls Guidance Docs in the FDA Guidance Document
  • Use Guidance Documents for Controls and Risk Management Requirements
  • Examine the guidance and determine which standards, testing, and hazard/risk analyses are appropriate.
  • Ensure extensive testing

How to demonstrate device safety?

The GHTF/SG1-N11:2008 in 10.0 Risk Analysis and Control Summary states that “The STED [Summary Technical Documentation] should contain a summary of the risks identified during the risk analysis process and how these risks have been controlled to an acceptable level. Preferably, this risk analysis should be based on recognized standards and be part of the manufacturer’s risk management plan.”

Factors to consider regarding risks before submitting 510(k)?

Human factors:

“Medical device manufacturers are required to follow FDA’s Human Factors guidance and regulations to help ensure safe use of these devices.” – CDRH website

Recognized standards include ISO 14971 risk management standard, IEC 62366 (joint ISO/IEC standard applying to all devices), IEC 60601-1-6 and AAMI HE75. To comply with standards,

  • Manufacturers will have to develop usability specifications for devices
  • Manufacturers should explore usability issues as part of the risk management process in compliance with standards
  • Include Usability evaluations as part of design validations

The FDA requires a summary of these actions as part of a human factors dossier while submitting pre-market information, which is explained in detail below:

  • Description of device user interface
  • Description of user interaction with UI (use scenarios)
    • Device, Training, Labeling, IFU
  • intended users, uses, use environments and training
  • Summary of known use problems from:
    • Predecessor devices
    • Similar devices
  • Analysis of hazards and risks associated with the use of the device
  • Summary of preliminary analyses and evaluations
  • Description and categorization of critical tasks
  • Details of human factors validation testing
    • Description of test participants (minimum of 15 in each user population)
    • Description of test scenarios
    • Moderator guideline
    • Training offered
    • Test results
    • Test results summary
  • Conclusion


Content of Software-related risk documentation.

In the 510(k) submission, medical device manufacturers must:

  • show they identified hazards appropriately and managed risks effectively and
  • provide traceability to link design, implementation, testing, and risk management.

The following information is picked from the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005

Device Hazard Analysis: Tabular description of identified hardware and software hazards, including severity assessment and mitigations.

Traceability Analysis: Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing.

When performing a hazard analysis, it is recommended that you address all foreseeable hazards, including those resulting from intentional or inadvertent misuse of the device.

The risk documentation for software can be in the form of an extract of the software-related items from a comprehensive risk management document, such as the Risk Management Summary described in ISO 14971. In this format, each line item should include:

  • identification of the hazardous event
  • the severity of the hazard i.e., level of concern
  • cause(s) of the hazard i.e., device Hazard analysis
  • method of control (e.g., alarm, hardware design)
  • corrective measures taken, including an explanation of the aspects of the device design/requirements, that eliminate, reduce, or warn of a hazardous event; and
  • verification that the method of control was implemented correctly.
  • Software Description
  • Software Requirements Specification (SRS)
  • Architecture Design Chart
  • Software Design Specification (SDS)
  • Traceability Analysis
  • Software Development Environment Description
  • Configuration management & maintenance plan
  • Verification/ validation Documentation
  • Revision Level History
  • Unresolved anomalies
  • Impact on safety or effectiveness discussion
  • Rationale for accepting

It is recommended to base your estimation of risk for your Software Device on the severity of the hazard resulting from failure, assuming that the failure will occur. You need to use risk identification and control techniques described in consensus standards such as ISO 14971.

Documenting risk in 510(k)

After analyzing the previous material, it is evident that ISO 14971 has identified a method for providing the information necessary by the FDA, namely the traceability summary required in Clause 3.5 of the risk management file.

The information can be provided in a document that is displayed in the GHTF guidance, GHTF/SG3/N15R8 Implementation of risk management principles and activities within a Quality Management System Annex C. 

Example of Risk Management Summary Table
Example of Risk Management Summary Table










Risk Traceability Summary

You can add a column with reference to the source document listing each hazard and additional information to improve the use of Risk Traceability Summary, for example:

  • A Human Factors or Usability study that identifies hazards
  • A standard that identifies a hazard and possibly a risk control method
  • MAUDE database identified hazard from predicate device
  • Complaint file from previous similar product

Risk Information in 510(k)

Provide a copy of the Risk Chart, which specifies the Risk Acceptability levels for the product in the submission, and include copies of the definitions of Severity Levels and the Probability of Occurrence Levels.

Take care of probability levels to ensure there is evidence to support the quantified levels and the ranges do not overlap.

Risk Chart Communicating Risk Management

Risk chart communicating risk management activities


Managing 510(k) is a tedious process, requiring data from various teams and several elements of test strategy. However, you can still navigate the process of organizing all the data in a simple yet comprehensive manner. It is important to remember that FDA reviewers can only review so much detail, and therefore randomly put together irrelevant data can cause delays in receiving approval. Therefore too much information can negatively impact 510(k) review timelines. It is a manufacturer’s responsibility to submit data accurately and present it in an easily comprehensible format. FDA can have many questions after the application is submitted, and they need to be responded promptly by going back to the source of data and responding to FDA to compress your approval cycle.

Leveraging Regulatory Management Technology (RIM) to build your medical device technical files and 510(k) submissions will help you avoid inconsistency, maintain clarity for managing submission requirements helping you streamline only those processes and parts of of section of your document that need additional detail.

About Essenvia

Essenvia is a regulatory lifecycle management solution to help you optimize the entire regulatory operations process. Our Regulatory Management Software solutions include an innovative approach to building your pre-market submissions like 510(k) and MDR/ IVDR as well as post-market submissions like Regulatory Change Assessment and Post Market Surveillance. Our solution reduces errors, streamlines regulatory process, and guarantees faster regulatory clearance for your medical device.

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The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

If a manufacturer plans to distribute a medical device to the market in the United States or Europe, the company must first ensure that the device is in compliance with each target region’s medical device classification requirements.

Determining the classification of a medical device can be tricky. However, medical device companies can use this comprehensive guide to understand medical device categories and where their products fall in line.

A basic understanding of regulatory product classification will become highly beneficial for manufacturers intending to become part of the medical device industry. Producers should consider the information below before introducing new products to the U.S. or European markets.

The Basics of Medical Device Regulations and Classifications

According to the European Commission, a medical device is any product or piece of equipment intended for use as a medical purpose. According to the U.S. Food and Drug Administration (FDA), the explanation of a medical device is a bit more detailed.

Based on the information within Section 201(h) of the U.S. Food, Drug, and Cosmetic Act, a medical device is an instrument, appliance, implement, machine, implant, in vitro reagent, or another similar related article:

  • Intended to diagnose, mitigate, cure, prevent, or treat disease in humans or animals
  • Designed to alter the structure or function of a human or animal body
  • Recognized in the U.S. Pharmacopoeia or the official National Formulary

By these definitions, medical devices can range from a basic cotton swab for COVID testing to a complex kidney hemodialysis machine. However, every device falls under the regulations of one or more regulatory agencies, such as the FDA in the United States and The European Commission’s European Medicines Agency (EMA).

These agencies have the responsibility to create laws to govern the manufacturing, distribution, and use of medical devices. The purpose of these laws is to ensure the safety and effectiveness of medical products, so all companies need to adhere to regulatory requirements the agencies set forth. The European Commission and its Member States began operating under a new policy framework as of May 2021, called the Medical Device Regulation (MDR).

The rules that would govern any new medical device depend on how the FDA and European Commission classify the products. Each agency has its distinct definitions of medical device classes, which generally outlines different product types’ perceived risk factors.

The FDA and European Commission have separate medical device categories. However, a class of medical devices will likely share similarities across both agencies, but with notable differences. Those responsible for introducing, marketing, and distributing new medical devices need to become very familiar with the legal policies and classifications of each agency.

How Does a Classification System Help Manufacturers?

The medical device classification systems and regulations help guide manufacturers in the following ways:

  • Regulations clarify requirements affecting product development, design controls, and the manufacturing process before selling a product to a particular market.
  • Knowledge of regulations helps a manufacturer to better predict costs and time frame for introducing a product to the market.

Understanding product classification benefits you as a medical device manufacturer or seller. Although multiple global regulatory agencies exist, we will focus on the primary two for this article: the U.S. FDA and The European Commission’s EMA.

Medical Device Classes in the United States

The U.S. Food and Drug Administration

The federal Food and Drug Administration is responsible for regulating medical devices in the United States through its sub-agency the Center for Devices and Radiological Health (CDRH). The CDRH states its mission as ensuring “safe, effective, and high-quality medical devices and safe radiation-emitting products.”

Due to the nature of their missions, the U.S. government mandates that the CDRH and FDA will ensure that all medical devices in the country are safe for use by providing the medical device manufacturing industry with “predictable, consistent, transparent, and efficient regulatory pathways.”

The FDA assigns medical devices to one of three classes. It bases its classification on the level of control that is necessary to make sure the device is safe and effective, as follows:

  • Class I: General Controls
  • Class II: General Controls and Special Controls
  • Class III: General Controls and Premarket Approval

A product’s assignment within the medical device classification system will determine the type of general controls necessary to regulate the devices. It will also determine the required type of premarketing submission or application for the FDA’s clearance to market a device.

Device classification relates to both the intended use and the indications for use of medical products.

  • Intended use refers to the general purpose of a medical product or what the manufacturer claim its function to be for patients or medical professionals.
  • Indications for use are the diseases or conditions the product will purportedly diagnose, treat, mitigate, cure, or prevent, associated with a description of the target patient population.

In other words, the intended use is all about the purpose of a medical device, while indications for use refer to what the product does to a particular illness or condition. A medical device’s intended use and indications for use directly correlate to the idea of the product a manufacturer wants to market.

Classification is also risk-based—that is, how much risk does the device pose to the patient or user?  Class I devices will carry the lowest risk, while Class III devices will present the highest risk.

How to Locate FDA Regulations for a Medical Device

Once a manufacturer can explicitly define the intended use and implications of use for a particular new medical device, they must locate FDA regulations and product codes that relate to their product. An FDA product code is a five- to seven-character figure containing numbers and letters. The agency uses it to describe a specific product.

It may take some time to identify a product’s regulatory classification with the FDA. The agency has several medical device categories based on medical specialties in CFR Title 21 – Food and Drugs: Parts 862 to 892. Examples of the specialties and regulation numbers include:

  • 862 Clinical chemistry and clinical toxicology devices
  • 864 Hematology and pathology devices
  • 866 Immunology and microbiology devices
  • 868 Anesthesiology devices
  • 870 Cardiovascular devices

A searcher should use the medical device’s definition for the intended use and implications for use to determine which category it best represents. Click the FDA regulation number to uncover a seemingly endless list of medical device possibilities.

Each regulation number opens a list of medical device descriptions. The manufacturer should there be able to find a suitable regulation for the product in question.

For each item on the list, a link opens up to provide more details about the regulations for that category, including the medical device classification and how well an intended use and implications for use line up with the rules.

After matching a proposed device with a regulation number on the list, a manufacturer must submit documentation, usually a 510(k), to the FDA in hopes of receiving market clearance.

Determining Applicable Product Codes for a Medical Device

After locating the applicable regulation and classification for a proposed new medical device, the next step is to find the applicable product codes. A search begins by going to the FDA Product Classification Database online and entering the regulation number from the previous search.

If multiple numbers appear to apply to the proposed medical device, the following process may be necessary for each number. After the number input, a search should generate a list of possible product codes. Clicking on each code should reveal more details about it. Using this process should help a manufacturer determine the best code for a specific medical device.

Understand a Medical Device’s Path to the U.S. Market

Knowing the application and product code for a medical device is necessary for determining a product’s classification and determining which path to take to register a product with the FDA.

Not everyone can register a medical device with the FDA. The process is more complex than merely submitting a basic application to the agency. Instead, the FDA uses three regulatory controls for all medical device classes:

  • General Controls are for Class I medical devices that are low to moderate risk
  • Special Controls are for Class II medical devices that are moderate to high risk. General controls also apply.
  • Premarket Approval (PMA) is for Class III medical devices that are high risk. General controls also apply.

If a manufacturer’s research determines that their specific medical device is “exempt,” it falls under general controls, and formal submission of an FDA 510(k) form will not be necessary. An exemption means the FDA does not require the manufacturer to provide reasonable assurance that the medical device is safe and effective. It usually applies to Class I devices.

An exemption means the manufacturer will not have to file a 510(k) form but still must register the brand with the FDA and list the product. If the product requires special controls, the manufacturer will need to submit a 510(k) to the agency. The FDA will need to provide the company with clearance before it can put the medical device on the market.

Devices that require premarket approval (PMA) must follow the FDA’s PMA process before going on the market. Through it all, the manufacturing company should register with the agency.

FDA 510(k) Submission vs. PMA Submission

Understanding the differences between a 510(k) and PMA submission adds to the complexity of medical device classification. Medical device classes will correspond to the specific premarket classifications named above, with the following stipulations:

  • Class I: These medical devices are basic and pose little to no risk to the user. General controls are acceptable for this class, and premarket submissions are unnecessary.
  • Class II: Products in this class can have a moderate risk to users, which is why all Class II devices require a remarket notification by way of a 510(k) form. Otherwise, they cannot legally go on the market. Devices in this category include sutures, powered wheelchairs, and pregnancy tests.
  • Class III: These devices have a higher risk for users than products in other categories because they sustain life or a medical professional can implant them into a patient. Examples include blood vessel stents and pacemakers. Class III devices must have a PMA submission before going on the market in the U.S.

When a manufacturer prepares and submits a 510(k), they must provide the FDA with documented evidence that proves the medical device is equivalent to a device that already has FDA approval. It usually takes the agency 30 to 90 days to review and approve these applications, after which the submission will be on display within the FDA 510(k) database.

To prove equivalency between a new medical device and another on the market requires comparing and contrasting the two devices, usually through laboratory testing. Helpful inputs to consider for a 510(k) submission include details from the documented Design Controls process, design inputs, intended use, and indications for use.

A PMA requires substantially more information than a 510(k) because devices that require premarket approval have a high risk. The PMA form proves to the FDA that a new medical device has exceptional safety and effectiveness for patients. Establishing this information usually requires laboratory testing and clinical trials with human participants.

Since the standards for a PMA are substantially higher than for a 510(k) submission, the FDA can take up to 180 days to accept or reject an application.

Medical Device Classes for European Union Member States

European Union’s Medical Device Regulation (MDR)

For countries within the European Union (EU), the Medical Device Directives by the European Commission now regulate medical devices.

Please note that since the United Kingdom left the European Union on January 31, 2020, it has its own medical device approval process that manufacturers must follow to receive a UKCA mark.

Within the EU, if a manufacturing company wants to make or distribute medical devices, it must obtain a CE marking. An EU medical device classification is necessary before obtaining a CE marking. The essential information for determining a medical device’s class is available in the European Union’s Medical Device Regulation (EU MDR).

As of May 2021, the EU MDR, specifically its Regulation EU 2017 /745, has become the mandatory regulation for medical devices. It amends the previous Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009.

The European Commission categorizes devices as Classes I, IIa, IIb, or III, depending upon the intended purpose and the device’s inherent risks.

Class I devices also break down into three subclasses: Is (sterile condition), Im (measuring function), and Ir (reusable surgical). Implantable devices and Class III devices require a mandatory premarket clinical investigation. A clinical evaluation consultation procedure is a requirement for certain Class III and Class IIb devices.

Under the EU MDR, a manufacturer should determine if a medical device is:

  • Non-Invasive: A medical device that does not enter a patient’s body through an orifice or the surface of their body. Non-invasive devices usually fall under Class I, but some rules can make them Class II or higher.
  • Invasive: These devices can enter a patient’s body, in whole or in part, either through the body’s surface or any orifice.
  • Active: These medical devices are active if their operation depends on an energy source other than what the patient’s body can generate for that purpose.

Although these categories are relatively broad, they come with specific rules, explained in the new medical device regulation.

In addition, a medical device that has continuous use for less than 60 minutes has a transient duration. Products with a duration for use between 60 minutes and 30 days are short-term. Durations exceeding 30 days are long-term.

It becomes easier to determine a medical device’s EU classification with those definitions in mind. In addition, the Medical Device Coordination Group published MDCG 2021-24 Guidance on classification of medical devices in October 2021. The MDCG, a group consisting of representatives from all EU Member States, resulted from the terms of Article 103 of Regulation (EU) 2017/745.

This document explains the basis of the EU MDR Classification Rules as “a set of criteria that can be combined in various ways in order to determine classification,” including examples such as:

  • Duration of contact with the body
  • Degree of invasiveness
  • Local vs. systemic effect
  • Potential toxicity
  • The part of the body the device affects
  • The degree to which the device depends on a source of energy

Understanding Your Medical Device’s Path to the EU Market

For any medical device to have a legal spot on the European Union market, the manufacturer must prepare and provide technical documentation to meet all general safety and performance requirements. The company must obtain a CE marking, a Unique Device Identifier (UDI) number, and registration within the electronic system (in accordance with MDR Article 29). Implantable devices have additional requirements.

Finally, the manufacturing firm must follow reporting requirements under the medical device vigilance system. Post-market surveillance is an ongoing requirement, meaning that all manufacturers must keep their clinical evaluations updated with relevant information stemming from post-market clinical follow-ups.

All companies need to work with an Authorized Representative to register their products in Europe.

Final Thoughts

With the resources and guidelines in this article, a manufacturing company should be able to take the appropriate path to the medical device industry’s biggest marketplaces in the United States and throughout the European Union.

Complying with regulations will ensure that a product’s quality and reputation remain top-notch, and it plays a role in the success of any manufacturing business.

Essenvia: Simplifying US FDA and EU MDR Applications

Regulatory agencies like the FDA and European Commission reject many medical device applications because of technical errors, omissions, and inaccuracies. Essenvia‘s Regulatory Information Management platform will streamline your application by offering templates, collaboration, and additional support across your device’s life cycle.

Complete your 510(k) or MDR application and launch your device faster with Essenvia. Schedule a demo now to learn more about how Essenvia can help you reduce time to market for your medical device(s).


Your Guide to European CE Mark for Medical Devices

Your Guide to European CE Marks for Medical Devices

Launching a new medical device is a highly regulated process whether you are looking to sell in the United States or other countries. To go to market within the European Union, you must first obtain a CE mark for your medical device. Please keep reading to learn about what a CE mark is, why it’s important, and how to get one.

CE Mark Meaning and Purpose

You may have encountered terms like EU MDR or the MDD medical abbreviation if you’ve researched this topic. These acronyms refer to the European Union’s regulations that ensure that legal manufacturers of medical devices adhere to their standards.

Before May 2021, these regulations were called the Medical Device Directives (MDD). The European Union Medical Devices Regulations (EU MDR) replaced the MDD in May 2021. For this article, we will refer to current regulations outlined by the EU MDR.

What Is a CE Mark?

A CE mark is a physical mark that goes on your product. It indicates that your medical device complies with the standards outlined by the EU MDR.

These regulations are in place to certify that your medical device is safe for users, performs as intended, and is a quality product. Once a new medical device has obtained a CE mark certification, it is ready to go to market within the European Union.

What Type of Medical Device Needs CE Marking?

Not all medical devices require CE marking, just those meant for commercialization within the European Union. A product meant for clinical testing or a custom-made device, for example, does not require CE marking. Devices that don’t need a CE mark must comply with other regulations, so do your research before introducing a new medical device.

Who Grants CE Marks for Medical Devices?

The manufacturer of the device can self-certify in some instances. For example, if your medical device is non-sterile and non-measuring, you can self-certify using the proper procedure outlined in the MDR. However, medical devices that pose a perceived risk to the user must obtain a CE mark certification from a Notified Body.

Securing a CE Mark for Your Medical Device

The process of securing a CE mark depends on the class of the medical device you are trying to bring to market. We discuss four classes within this article. We do not include in-vitro diagnostic devices because these devices have special requirements.

For all other devices, the manufacturer must follow the appropriate conformity assessment procedure for the class of their medical device. Generally, the classification of a device depends on the level of risk associated with it:

  • Class I: Low risk
  • Class IIa: Low-medium risk
  • Class IIb: Medium-high risk
  • Class III: High risk

A variety of factors determine the perceived risk level, including whether or not the device is sterile, if it has a measuring function, how invasive it is, and how long it is meant to work.

Low risk, Class I medical devices are further sub-divided into four sub-classes:

  • Class I – Non-sterile devices, or products without a measurement function (e.g., facial mask, gauze, gel for ultrasound).
  • Class Is – Product that is delivered sterile and must be either transported in a sterile condition or sterilised on receipt (e.g., sterile gauze, sterile gown for the surgeon, sterile syringe).
  • Class Im – Device with a measuring function (e.g., syringe with measurement function, spoon for giving antibiotics).
  • Class Ir – Reprocessed or reused products (e.g., instruments for dental examination, surgical instruments such as scissors, tweezers, lancets).

The risk level of the assigned classification of the medical device will determine which conformity assessment path must be followed for that medical device.

What Are the CE Mark Requirements for Medical Devices in Each Class?

Once you identify which class your medical device belongs to, you can determine what steps are necessary for CE marking certification.

The guide below should not replace the EU MDR, but we hope it is helpful. Refer to the official regulations if you have specific questions, or send our experts an email.


Here are some helpful definitions of terms used in this section.

  • Notified Body: Organization chosen by the national regulatory body that assesses how well your device meets the regulatory requirements
  • Competent Authority: A part of the EU Member State’s government that oversees regulation compliance
  • Quality assurance system: Also called a quality management system, this system manages processes to ensure regulatory compliance and prevent defects
  • Annex III examination: A procedure performed by the Notified Body that ensures regulatory compliance of a device production sample

Class I

For Class I medical devices, the manufacturer may satisfy CE marking requirements by themselves. These products do not require the participation of a Notified Body and:

  • present minimal risks to users
  • are classified as non-sterile
  • do not include a measuring function
  • are not reused

Some examples of Class I medical devices that can be self-declared are eyeglasses frames, non-sterile dressings, and walking aids.

Class I Self-Certification:
  • Prepare a CE marking Technical File
  • Prepare a Declaration of Conformity
  • Register with the Competent Authority (if not already done)

Not all Class I devices can be self-certified. If the device is sterile, like a needle, a Notified Body must certify it. You must also obtain Notified Body certification for a device with a measuring function, i.e., a stethoscope. Reusable devices, such as surgical tools not attached to an active medical device, also need Notified Body certification.

Class I Certification for Sterile and Metrologic Devices:
  • Prepare a CE marking Technical File
  • Acquire an assessment from a Notified Body on sterility or metrology
  • Prepare a Declaration of Conformity
  • Register with the Competent Authority (if not already done)

Class IIa

Devices in the Class IIa category are for short-term use (30 days or less), such as tubing intended for drug delivery, syringes, and surgical gloves. These devices present a low to medium risk to the user. All Class IIa medical devices require the involvement of a Notified Body to obtain CE mark certification.

Class IIa Certification
  • Prepare a CE marking Technical File
  • Acquire a quality assurance audit from a Notified Body
  • Prepare a Declaration of Conformity
  • Register with the Competent Authority (if not already done)

Class IIb

For Class IIb medical devices, the risk level elevates to medium-high. Intended for long-term use, these devices remain in use for more than 30 days. Examples include invasive devices like orthopedic plates and larger machines, such as incubators and defibrillators.

A Notified Body must participate in the certification process.

Class IIb Certification
  • Prepare a CE marking Technical File
  • Acquire one of the following from a Notified Body:
  • A full quality assurance system audit
  • An Annex III examination
  • Prepare a Declaration of Conformity
  • Register with the Competent Authority (if not already done)

Class III

Class III medical devices are considered high risk and often require lifetime monitoring. Examples include internal pacemakers, prosthetic heart valves, and replacement joints. Notified Body certification is required for all Class III medical devices.

Class III Certification
  • Prepare a CE marking Technical File
  • Acquire one of the following from a Notified Body:
  • A full quality assurance system audit and Design Dossier approval
  • An Annex III examination and a product examination or test
  • An Annex II examination and a production quality assurance system audit
  • Prepare a Declaration of Conformity
  • Register with the Competent Authority (if not already done)

After Obtaining Medical Device CE Mark Approval

Once you have obtained a CE mark certification, you have one more step to complete before bringing your product to market: put the CE mark on the product.

There are a few requirements for the CE mark:

  • The mark must be readable
  • The device should display the mark permanently
  • The mark must include the Notified Body’s four-digit NB number (unless self-certified)

Once you have your CE mark on your device, you’re ready to launch within the European Union.

Will I have to do this process again for the same medical device?

Yes. CE certifications typically last for three years.

What if my CE mark was issued before May 2021?

Certificates issued before the MDR came into effect will remain valid for up to five years. However, all CE marks allocated before the MDR went into effect will automatically become invalid four years after May 2021.

What if I change a critical supplier after obtaining my CE marking?

You must notify your Notified Body if an important supplier changes to get an updated CE certification. This process may include a new audit by the Notified Body.

Streamline Your CE Mark Application

Applying for a CE mark is a complicated process. We hope our guide provides clarity on the topic, but if you still need help, Essenvia can get you through this lengthy process faster and with more confidence.

The Essenvia platform simplifies the CE marking process by consolidating information, documents, and templates, auto-filling basic information, and eliminating discrepancies and mistakes. Our templates are also compliant with the MDR, so you always get the latest versions for easy compliance.

When you work with Essenvia, you’ll save time, ensure the accuracy of the information, get real-time status updates, and produce a professional, error-free application! Request a demo today to get started down the right path to obtaining a CE mark for your product.

Posted in EU

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

Manage GSPR (General Safety And Performance Requirements) in Essenvia

What is GSPR?

The GSPR stands for General Safety and Performance Requirements as listed in Annex I of EU MDR 2017/745 and EU IVDR 2017/746. These requirements are similar to the Essential Requirements under MDD 93/42/EEC.

The GSPR has 23 requirements under EU MDR and 20 requirements under EU IVDR. The manufacturers who wish to get CE mark for their device have to establish conformity with these requirements and should provide sufficient evidence to demonstrate compliance with GSPR. GSPR is a core element to navigate CE marking for a device.

GSPR Chapters and Requirements Guide:

EU MDR 2017/745EU IVDR 2017/746
Chapter 1 – General requirements (1 to 9)Chapter 1 – General requirements (from 1 to 8)
Chapter 2 -Design and Manuf. (from 10 to 22)Chapter 2 – Performance, Design and Manuf. (from 9 to 19)
Chapter 3 –Labels and IFU (23)Chapter 3 – Labels and IFU (20)

Essential Requirements for EU MDD and EU IVDD

The Medical Device Directive (MDD) defines the “Essential Requirements”, as the requirements that every medical product has to fulfill, according to the scope they belong to. These essential requirements are described by Directive in Annex I, 93/42/EEC for EU MDD and 98/79/EEC for EU IVDD, and there are in total 13 requirements.

Essential Requirements Chapters and Requirements Guide:

Chapter 1 – General requirements (1 to 6)Chapter 1 –General requirements (from 1 to 5)
Chapter 2 -Design and Manuf. (from 7 to 13)Chapter 2 -Performance, Design and Manuf. (from 1 to 8)

Layout and Structure of the GSPR

The General Safety and Performance Requirements (GSPR) are divided into the following 3 chapters:

1. General requirements

  1. Intended purpose, safety of patients, users and other persons
  2. Reduction of risks
  3. Risk management system
  4. Risk control measures
  5. Risks related to use error
  6. Device performance shall not be adversely affected
  7. Device design, manufacture, packaging
  8. Risk reduction, acceptable risk-benefit ratio
  9. General safety requirements for devices without an intended medical purpose as described in in annex XVI

2. Requirements regarding design and manufacture

  1. Chemical, physical and biological properties
  2. Infection and microbial contamination
  3. Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances/substance combinations that are absorbed by or locally dispersed in the human body
  4. Devices incorporating materials of biological origin
  5. Construction of devices and interaction with their environment
  6. Devices with a diagnostic and measuring function
  7. Protection against radiation
  8. Electronic programmable systems – devices that incorporate electronic programmable systems and software that are devices in themselves
  9. Active devices and devices connected to them
  10. Particular requirements for active implantable devices
  11. Protection against mechanical and thermal risks
  12. Protection against the risks posed to the patient or user by devices supplying energy or substances
  13. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

3. Requirements regarding the information supplied with the device

  1. Label and instructions for use

Essential Requirements vs GSPR

EU MDR and EU IVDR replace the EU MDD and EU IVDD for CE Mark in Europe. As shown in the table above, the Essential Requirements of the MDD are divided into 2 chapters with 13 items while MDR has 3 chapters with 23 items. This means that the changes from MDD have not only shifted quite a bit, but the scope of the details in requirements has also increased considerably with MDR.

To understand the extent of changes, items covering “Information provided by the manufacturer” from Chapter 2 in Essential Requirements have now been reorganized and incorporated into a new chapter 3 in GSPR.

Additional requirements and some administrative simplification for MDR come from the fact that the MDD has been combined with AIMDD (Active Implantable Medical Device Directive ER) and is now covered within GSPR Item 19. Further, in MDR’s GSPR a number of topics have been given greater emphasis or have been dealt with in more detail.

Besides expanding on some key aspects, several topics are newly incorporated in the requirements list of the GSPR. These include but are not limited to:

  • Requirements for devices that administer (GSPR 10.3/4) or contain drugs (GSPR Item 12)
  • Specific requirements for devices that contain tissues of human or animal origin (GSPR 13)
  • Requirements for disposal (GSPR 14.7/23.4)
  • Requirements for IT safety (GSPR 17.4)
  • Requirements for devices for use by lay persons (GSPR 22)
  • General requirements for labelling (GSPR 23)

Chapter 1 of GSPR

Chapter 1 in GSPR has many similarities with the MDD. However, there is a higher emphasis on usability and dependability along the product life cycle and the state of the art. Paragraphs 2 – 5 of Chapter 1 stress on risk management and the importance of medical devices. While paragraph 9 of Chapter 1 addresses devices without an intended medical purpose, the other paragraphs are very similar to the MDD and depict the “standard” requirements for every medical device.

Chapter 2 of GSPR

Key highlights as it pertains to changes from chapter 2 of GSPR are outlined below:

  • Paragraph 10 provides more details for the chemical, physical and biological properties, especially as it relates to handling of toxicity and specific substances
  • Paragraph 11 addresses requirements on infection and microbial contamination
  • The scope in paragraph 12 is extended to include substances absorbed or locally dispersed by the human body
  • Paragraph 13 now includes non-viable human tissue in the biological tissue category
  • New regulations have also been added for the interaction of medical devices with the environment (paragraph 14) and the compatibility with other devices
  • Network and cybersecurity has grown in importance within the global medical device diaspora and as such they are given high importance in the GSPR
  • Regulations for mechanical and thermal risks as well as risk reduction have also become more detailed

Chapter 3 of GSPR

In chapter 3 of GSPR, paragraph 23 “label and instructions for use” is covered in detail. In general, this chapter handles significantly more requirements, such as the format of the instructions for use, readability, comprehensibility, availability, and how this relates with laypersons in addition to professionals. This chapter also covers additional requirements that must be fulfilled for UDI labeling as well as devices containing human or animal tissue. The same applies to the labeling of sterile packaging or the indication of Carcinogenic Mutagenic and toxic to Reproduction (CMR) substances.

Transitioning from MDD to MDR and from IVDD to IVDR

From 26th May 2020 to 25th May 2024, CE mark certificates issued under the MDD, before the MDR fully applies, will be valid for up to 4 years. From 25th May 2022 to 25th May 2024, CE mark certificates issued under the IVDD before the IVDR fully applies may remain valid for up to 2 additional years. From 26th May 2024, all devices placed on the market must be in conformity with the MDR or IVDR.

Below is an infographic showing the transition timeline for medical device manufacturers in Europe:

MDR and IVDR Transition Timeline - GSPR (Essenvia)
MDR and IVDR Transition Timeline

Challenges of Maintaining GSPR

From a regulatory point of view, there has been no fundamental shift with the introduction of GSPR. It is still crucial that the safety and performance of medical devices are proven. This must be acceptable within the given clinical context and the manufacturer needs to ensure that the two components do not change significantly during the entire life cycle of the medical device. That is why a systematic risk management process is required, which must be updated constantly, even after the device is in the market.

Yet another challenge with the GSPR lies with the fact that many state-of-the-art requirements from harmonized standards have been incorporated directly into the MDR. However, no annex from the harmonized standards refers to the GSPR in the MDR currently. Meaning, manufacturers will still need to perform a careful gap analysis in order to establish the relation until no uniformity exists between the two.

The objective evidence that the GSPR is fulfilled is part of the Technical File. Also, during the selected conformity assessment procedure, it must be proven that the requirements in GSPR are fulfilled.

Best Practices to Streamline GSPR For your Medical Devices

GSPR as such is not just another document to be updated, but rather a critical artifact that guides the development process and decisions from the outset for a manufacturer. Therefore, medical device manufacturers should promptly prepare a new checklist for the General Safety and Performance Requirements (GSPR) according to Annex I of MDR and IVDR to ensure the new GSPR is implemented and complied timely.

Using the GSPR checklist is practical and ensures traceability and completeness, but the number of items and the ongoing process of adding references to evidence and methods of conformity in the form of searching and linking 100s of standards, evidence documents, or procedures especially as they change and evolve requires the constant upkeep and maintenance of GSPR for products.

Essenvia’s Regulatory Management tool allows you to easily maintain GSPR for your products and variants. It serves as a single source of truth that links to standards databases and evidence documents and reports within the platform, helping you easily cross-reference methods of conformity whether these are harmonized standards, procedures from your quality system, or testing reports. Easily create, publish and link new versions of the GSPR with the Technical File to maintain compliance with Annex I requirements for the MDR.Schedule a demo now to find out how Essenvia can help you with your regulatory submissions.

Posted in EU

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy


Medical device manufacturers who intend to introduce a device into commercial distribution in the United States must submit a premarket notification – 510(k) or PMN to the FDA.This rule is applicable whether you are introducing a device for the first time, or planning a reintroduction with significant modifications. To ensure this rule is followed, you must leverage the information found in the FDA 510 (k) database.

This regulatory submission allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. These categories include: Class I or Class II- with or without exemptions or Class III Premarket Approval (PMA).

If your device is classified as Class I or II, and if it is not exempt, a 510(k) will be required for marketing.

510(k) Submission Pathway:

A 510(k) is a premarket submission that needs to be sent to the FDA to demonstrate that the device to be marketed is safe and effective. It will also prove the device is substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

Once the device is determined to be substantially equivalent and cleared by FDA it can then be marketed in the U.S. The substantially equivalent determination is usually made within 90 days. This determination is based on the information submitted by medical device company seeking the clearance.

However, before you decide whether your device is eligible for the 510(k) pathway it is critical that you understand the regulatory strategy for your device.

The important elements of a regulatory strategy include:

  • FDA Product Code
  • Regulation Number
  • Proposed Indications For Use
  • Testing requirements
  • Product and device-specific guidance documents

In the paragraphs to follow we explain how the FDA 510(k) database is the ideal resource for medical device manufacturers to assess and determine their regulatory strategy to market.

How to use the FDA 510(k) Database to assess your regulatory strategy:

FDA maintains a database of previously cleared 510(k)s on its website. Typically, they will add new devices around the 5th of each month for devices cleared in the prior month. Users can search for previously cleared 510(k) submissions from this database using search criteria such as but not limited to:

  • 510(k) Number
  • Applicant Name
  • Product Code
  • Device name

Steps to performing an efficient 510(k) database search:

The following steps outline how to use the FDA 510(k) database to create your regulatory strategy and manage ongoing updates:

  1. Prepare your 510(k) search criteria:

    1. For creating an effective regulatory strategy it is extremely important to take a methodical approach. The first step, therefore, is to document the technological characteristics, the intended use, and the desired indications of use for your device. Also, identify intended users of your product. This may include patients, caregivers, or healthcare professionals.
    2. Build your initial keywords list based on the important attributes describe the technology (for example a needle, a catheter, etc.). This key word list also includes the indications and mode of action for the device. These keywords are attributes that when combined represent your device.
    3. Identify and list your competitors and the devices they have marketed or received approval for. We will talk about how to use this information later in this article.
  2. Perform a search of the 510(k) database

    1. There are two ways to run an efficient search on the FDA 510(k) database: (1) Quick search and (2) Advanced search. We will discuss how to leverage each of these search methods to optimize this FDA resource.A quick search on the 510(k) database with your keywords is helpful to identify a list of devices that match your device category.Below is an example of how this search works using an apnea monitor as the device
    2. Click search to view the list of devices that have a name apnea on them. This lists the devices with the keyword Apnea in them with decision dates and applicant information, all of which is valuable information that you can use for your own application.
    3. Click on the device name to see the regulatory attributes such as medical speciality, common name, and regulation number, and text. Scan the list and note down the products and regulatory attributes that look relevant. Also, click on the 510(k) Number and note down additional details for further use in the advanced search.
    4. The advanced search screen (shown below) is helpful when you already have key data on your competitors such as their 510(k) number or three letter product code. It is also helpful if are already confident the device in questions is similar to yours.
  3. Assimilate results, compare relevant attributes, and rank order search results

    Now that you have collected product code, regulations, and summary documents of possible similar devices, it is time to compare them with your technology, indications, mode of action and components. As well as, identifying the one that is closest to your device.This will then help you identify the applicable tests and guidance documents relevant to your device. This will inform your broader regulatory strategy and therefore your budget and timelines to go to market.

  4. Managing Regulatory strategy and ongoing regulatory Intelligence

    Regulatory assessment is a task that medical device companies must complete regularly in order to stay current with the latest regulatory changes. It is paramount that regulatory teams maintain a proactive approach to understand and assess the impact of changes to regulations, standards, and new guidance documents published by FDA, as well as device recalls of similar devices or changes in the product category.

    Methods used today include manually searching in guidance documents, standards databases, recalls and MAUDE reports databases that FDA has made available for public search. A slightly more sophisticated approach is subscribing to a plethora of industry journals, attending conferences, subscribing to FDA newsletters and notifications to stay up-to-date.

    The problem with this approach is regulatory affairs specialists and leaders end up consuming a lot of data from disparate data sources and struggle to make sense out of it all. This requires an audit of these sources to narrow down the information relevant to your device. Then, you need to assess what you just learned and recommend a course of action. With the number of rapid changes occurring every day, these approaches quickly become unmanageable.

Limitations of the current process to search in FDA 510(k) Database:

Whether you are using keywords-based search or competitor data for regulatory strategy, these searches can take hours. You also risk the possibility of omission due to the time the number of records that need to be reviewed.

Evaluating competitor technology could be helpful. However, elements such as technological characteristics, materials, and mode of action do not always equal a device that you can use to show substantial equivalence.

Therefore, finding the right substantially equivalent device seldom involves a straightforward strategy. Instead, it is the result of hours of careful preparation of a combination of keywords. This list that can identify a list of devices already in the market and then doing a couple of passes to compile a list of devices and technology.

The siloed process of passively managing regulatory attributes, strategy, and search criteria while spending hours scouring the internet is time-consuming and prone to error. Reviewing the regulatory attributes alongside the technology profile will help you identify the ideal devices to use to establish substantial equivalence.

A better way to manage regulatory search and intelligence

What if there is a way to combine all the steps mentioned above and streamline the entire process? A tool that can allow you to preview and analyze critical regulatory attributes for specific devices that are ranked by relevance based on your list of keywords.

What if you were are able to pull the documents from previous searches? What if your team could leverage a system that understands important attributes and can also notify you when changes occur.

As busy regulatory specialists, leads, and executives in medical device companies, your strength lies in your ability to make great decisions substantiated by data points. Therefore access to relevant regulatory information curated without noise can save hours and sometimes days and it can be a long-term competitive driver of medical device innovation.

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

When you are in the early stages of developing a medical device, over half of your activities are regulatory-related. Therefore, having an optimized and efficient regulatory affairs operations is critical. It will be the difference between getting your device to market on time or suffering a crippling setback.

Automation is one of several key factors that allow you to optimize your entire regulatory affairs process. Without it, you leave yourself wide open to an array of potential mistakes. For example, manually compiling over 1,100 pages of content can lead to an accident such as omissions an discrepancies.

These critical errors can cause delays that cost your company thousands, if not millions of dollars. Depending on your current financial situation, that might be a type of loss your company cannot recover from. This type of financial setback can turn those avoidable missteps into fatal ones.

However, the right automation tool can transform your regulatory operations and make sure this never happens. The key is to invest in a platform that provides you with crucial submission insight. This includes a complete go-to-market strategy, understanding the required testing your device needs to complete, and more. Leveraging the power of automation is a choice you cannot afford not to make.

The Rapid Evolution of Regulatory Policies

Regulatory rules and policies change and shift at a rapid rate. Medical device companies are constantly facing the challenge of balancing these regulatory requirements with the commercial viability of the device they are bringing to market. Failing to strike the right balance in this area can be the difference between your device getting to market and watching it die before it even has a chance to succeed. It is up to a companies regulatory affairs team to balance these competing priorities.

However, a team is only as effective as the operational process they implement and follow. It’s important to understand the importance of an optimized regulatory process. To do this we must better understand the complexity and magnitude of the rapidly evolving library of regulatory requirements. Only then can we truly grasp the workflow required to manage the widening range of medical technologies.

The Role of Regulatory Affairs

The sheer number of relevant guidance documents, testing protocols, and submission checklists a regulatory affairs team must include in their submission presents a massive challenge. This high volume of data and information presents several potential areas for mistakes. If you are not careful, your chances for a successful pre-market application in jeopardy.

Not to mention, submitting regulatory submissions is only part of the job description for regulatory affairs specialists.. They also contribute to the regulatory strategy by gathering competitive intel using the FDA 510k database and coordinating with cross-functional teams.

They also must consistently monitor changes to product codes, guidance documents, and standards. This issue can be seen on full display when looking at the FDA’s refuse-to-accept rate when it comes to reviewing regulatory clearance applications.

A surprising 31.3% of applications get rejected before even initiating the review process and are forced to withdraw due to errors. This requires your team to go back into the 1,100+ page document, find and correct the mistakes, and start the process again. This delay in getting your device to market can cost your company millions of dollars.

Managing Your Cross-Functional Teams

It takes a village to manage the regulatory process for a medical device. While one person may run point on the entire project, they rely on significant help from their cross-functional teams. This includes design, labeling, sterilization, clinical and quality departments. For this type of collaboration to work, all relationships must be built on the following four pillars:

  1. Ensuring everyone has access to the latest regulations, guidances, forms, and templates required by the regulatory authorities you are submitting into.

  2. Following project management procedures that create a seamless workflow amongst all cross-functional teams.

  3. Identify and eliminate/reduce repetitive manual tasks that only serve to delay progress and cause errors.

  4. Establishing a relationship with a regulatory affairs expert who can provide specific guidance based on your device based and the regulatory testing required by the region you are launching in.

Setting up these pillars at the start of your regulatory pathway is vital. Once your initial regulatory strategy is set up, the cross-functional teams listed above will be responsible for supplying various types of documentation for your submission. The data and content will be based on several factors, including the type of device, applicable regulations, changes to the device, manufacturing site, materials, and more.

Having Access To The Latest Regulations Guidance Documents That Impact Your Device

The average length of a 510(k) submission has reached 1,185 pages. This is a staggering 150% increase since 2009 and a direct result CDRH’s actions to clarify and strengthen 510(k) submission expectations. The FDA and European Commission (EC) have issued hundreds combined new guidance documents with 50% of them being released in just the last two years alone.

These new guidance documents can have a significant impact in the trajectory of your device. Furthermore, these consistent updates force your regulatory team to spend 4-6 hours a week keeping up with the latest developments. This is a time that can be much better spent working with cross-functional teams to collect and review all content before it is added to the submission.

Guidance documents are crucial to the regulatory lifecycle of your device because they identify several key changes. This includes, but is not limited to: UDI Management, device registration, and listing management. Failure to stay up to date on these changes can result in the aforementioned fatal mistakes we mention earlier.

Eliminating Costly Mistakes and Expediting Time To Market

One of the most time-consuming parts of compiling a regulatory submission is collecting, organizing, and revising key content such as tables and graphs. In addition, once all of your tables and graphs are uploaded, you must make sure they are correctly numbered.

However, what happens when a team member sends you a new table or graph that needs to be placed amongst the assets you already have in place? This often results in having to go through and re-number the majority of the list. These types of manual tasks only serve to waste time and increase your chances of making a costly mistake.

Asset numbering is just one of several types of administrative tasks your team is responsible for executing. This type of extended manual labor increases the odds of making a crucial mistake. Furthermore, once everything has been double-checked, it is then time to publish your 1,100+ page submission into a format that the regulatory body will accept.

This administrative burden will add weeks to your regulatory submission timeline. Optimizing your process by using automation tools makes sure that does not happen. The right tool will re-number your remaining assets after an addition has been completed. Automation tools go through a complete checklist to ensure you have included every step you need to complete.

No matter how long you have been working on regulatory submissions, it’s unreasonable to think you can learn everything. This is because of how rapidly things change in the medical device regulatory industry. With everything else going on, you do not have time to keep on top of everything. Leveraging an automation tools makes sure every box is checked, every document is formatted correctly, and you end up with rejection-proof and regulatory body-abiding submission.

Having Access To An Expert That Understand The Regulatory Requirements For Your Device

While your team may be excellent at creating and organizing content and data, they will undoubtedly run into an issue they cannot solve independently. The regulatory requirements for each device vary based on several factors, and it can be challenging to understand which applies to your device. Optimizing your regulatory process becomes meaningless if you don’t understand which steps you need to take.

Regulatory consultants are external experts who have the knowledge and experience to help you understand the regulatory landscape for your specific device. They can also be beneficial depending on the location you are seeking clearance in. For example, if you seek clearance outside your primary country, you must work with an authorized representative in-country. The right regulatory expert can walk you through this entire complex process.

Let’s Recap

Optimizing your regulatory operations saves serious time and money. The regulatory lifecycle of your medical device is long and complex. Without automation, you are forced to perform tedious administrative tasks that open you to all types of errors and delays. The right automation tool takes all of this off your plate and provides the peace of mind you need to move forward to compile an accurate regulatory submission on time and under budget.

About Essenvia

Essenvia is a regulatory lifecycle management tool designed to help you automate the entire regulatory operation process. Our solutions include an innovative approach to building both your 510(k) and MDR submissions. Our software is designed to reduce errors, streamline processes, and guarantee faster regulatory clearance for your medical device.

To better understand how your tool can benefit you, please schedule your free demo.

Essenvia Spaces: All Your Medical Device Data In One Place

Being in charge of a device’s regulatory information is complicated enough. Being tasked with managing this type of data for various devices can be overwhelming. Even if you are only working on one device, you deserve the ability to organize and manage files, processes, and projects related to regulatory submissions.

Essenvia was born out of a need to streamline the regulatory process throughout the entire lifecycle of a medical device. Spaces is the latest step in that journey.

What is ‘Spaces’?

Currently, on the Essenvia platform, every project created for a specific medical device operates in its own silo. In other words, if a piece of your device’s master information changes in one project, you must manually make this change in the other projects. Spaces solves this tedious and time-consuming issue.

‘Spaces’ is shorthand for ‘Device Workspace,’ and it’s our solution to help you manage all the regulatory submissions related to a particular medical device. As an account administrator or space owner, you can create a ‘Space’ for each device you are working on.

Then, you create all projects associated with the device in its own dedicated space. This way, you only need to fill in the Master Information once. Then, it will be automatically cascaded into all projects related to the device. This removes the need to re-enter the exact details repeatedly for each submission.

A Must Have For Managing Multiple Devices

Spaces are vital in efficiently managing multiple projects and documents for the same medical device. It is also the ideal solution for regulatory managers in charge of managing a portfolio of devices. Regulatory consultants who support multiple projects and clients simultaneously can take advantage of the advanced permissions features. It is now easier for consultants to manage permissions for their customer’s regulatory projects, files, and devices.

Spaces was designed to optimize how a device’s regulatory management as it moves from stage to stage. Our tool ensures crucial information, files, and data stay consistent. It also allows sharing and collaboration to be easily managed. This is a key component when creating an expedited and accurate regulatory submission.

Aligning On Your Device’s Key Information And Other Medical Device Data

A core function of the Essenvia platform is to capture your Master Information at the beginning. This includes all of your applicant, device, and regulatory details. Spaces ensures that the vital information you entered at the start is shared across all the projects (submissions) within the space. If that information suddenly changes, those changes are then automatically cascaded across all submissions.

Spaces ensure that the data we collect is shared with every member of your team. When everyone is working off the correct information, the likelihood of errors and delays drops significantly.

If a piece of your master information changes, your entire team must be notified. Otherwise, you have team members creating documents with outdated data. That type of mistake can force you to waste time fixing errors. Even worse, if it is not caught in time, it could cause your regulatory authority to reject your submission entirely.

Tracking Your Team’s Access and Permissions

Pushing a device through critical regulatory milestones requires plenty of help from your functional teams. Spaces are perfect for providing a central location to make their contributions. However, we are fully aware that some contributors require more access than others. Plus, your internal team members will likely need greater access than external vendors

Spaces allows you to keep complete control over who has access to your space and how much they can do and see. In addition, our varying permission levels will enable you to grant access based on need. For example, a design agency creating your images does not need the same level of access as a research specialist or project manager.

Track All Key Aspects Of Your Space and Medical Device Data

A medical device will encounter hundreds of changes throughout its regulatory lifecycle. This will include new submissions, key information updates, tables, reports, files, etc. Spaces allow you to track all the activity within the space so that you have an activity log that captures all the updates or changes as required by the regulatory authorities

How To Learn More About Spaces

Spaces was created to optimize the regulatory process across the entire lifecycle of your medical devices. Our latest feature is ready to help streamline managing different submissions for each device, reducing repetitive work and errors, and manage all aspects of your device’s regulatory life cycle.

If you are interested in scheduling a demo session, CLICK HERE.

To learn more about Essenvia and the features we offer, CLICK HERE.

5 Reasons You Shouldn’t Work on Your 510(k) Submission Alone

First, you conceptualize your idea for a new medical device. Your team has determined what medical issue it is going to resolve and how it will be used. Then, you research the current state of the market to understand the level of need and how to best position it. Your cross-functional teams spend time designing your device and ensuring it is easy to use. Finally, you are ready build your 510(k) submission to submit your device for FDA clearance.

 Obtaining FDA clearance for your device involves submitting a 510(k) application. This application is normally over 1,100 pages and requires a plethora of information. The sheer size of this application will leave you open to all types of mistakes. Theses mistakes can lead to your application being rejected.

The FDA will provide general guidance regarding what needs to be included in a 510(k) application. However, they provide little else in terms of document organization or project management. This often leaves submitters alone with a checklist and blank Microsoft word document. Then forced to wrangle hundreds of pages of information such as packaging labels, clinical trial reports and more.

In this post, we cover the top 5 reasons why you should not go it alone when submitting your 510(k) application.

#1 – You Need To Have The Most Up To Date FDA Documents

Your 510(k) application, you will include several places that require FDA documents. The FDA will supply these documents as they are necessary for submitting a complete application. However, documents and forms such as your Cover Sheet, Indication of Use, and Declaration of Conformity to a Recognized standard change often. It can be difficult to know if you are using the most up-to-date version. The last thing you want is to learn you are not compliant by having your application rejected.

These types of requirements can lead to errors among those who are doing this on their own. However, using a 510(k) application builder tool like ours ensures you always have to right templates. We automatically populate your application with the most up-to-date FDA templates. All you need to do is fill in the necessary information.

For example, the FDA requires a specific form for your device’s Indication of Use statement. This document explains what you plan to use your device for after receiving clearance. This is also a document that the FDA tends to update regularly. As anyone who has used the FDA website will tell you, these documents are not easily accessible. Our 510(k) builder always provides the most up-to-date form and automatically inserts it into your application.

#2 – Discrepancies and Errors Will Lead To Rejection Of Your 510(k) Submission

A key reason automation has become so popular in today’s society is it cuts down on both time and errors. Brands no longer require their sales reps to manually type out their outreach emails because it is highly likely there will be a typo or incorrect statement. The pitfalls of manual data entry are just as evident when it comes to 510(k) applications.

The application will require you to repeat the same key information such as indications for us and device descriptions in several places. For example, your indication of use statement is a key point that the FDA will review. Even if you are clear on what that statement is, it’s possible it can be phrased in several different ways.

If the reviewer feels this statement is inconsistent, they will reject your application. In our application builder, we ensure this type of content is consistent throughout your entire application. All you need to do is type it once and our Changelock™ function ensures your information cascades to all relevant sections throughout your application.

#3 – You Have A Lot Of People You Need To Communicate With

As the saying goes: If you want something done right, do it yourself. Regardless if you agree, one undeniably true fact is that you cannot compile the data and information you need for a 510(k) by yourself. As the project lead, you are required to communicate with several people both inside and outside your organization. This requires countless emails, dropbox folders, JIRA tickets, and anything else that delivers the content you require.

Ongoing communication amongst this many parties is ripe for confusion and errors. This is due in large part to your teammates not being well versed in regulatory terminology. They are also not nearly as knowledgeable as you are about the various requirements set by the FDA. Therefore, it is your responsibility to translate their work into content that follows the proper terminology and requirements.

A system must be put in place on day one. A process that allows you to get a handle on the various documents that are floating in your direction. You will benefit greatly from a program that helps collect this information and store it in an organized manner. This will relieve your stress and allow you to confidently move forward knowing you have the most up-to-date and accurate versions of everything you need.

#4 – The Fear and Anxiousness Of Getting You 510(k) Submission Wrong

Gaining FDA approval is a daunting and pressure-packed task. This is the major hurdle stopping your device from hitting the market and turning a profit for your organization. Key stakeholders including executives, shareholders, investors, and team members are looking for you to deliver. Messing up could mean a loss in revenue, decreased profits, and possibly even losing key investments. That scenario is enough to paralyze anyone with fear and anxiety.

While you cannot minimize the importance of a 510(k) application or decrease its size, you can determine the best way to approach it. This includes setting up a process that safeguards against errors, discrepancies, and the use of outdated documents. When you leverage the power of our app builder, you no longer fear making a crucial mistake such as using the wrong template or forgetting to update a section of your application. Your anxiety will significantly lessen knowing you took the necessary steps to produce an error-free and rejection-proof application.

#5 – Your Time Is Better Spent On Other Sections Of Your 510(k) Submission

The truth of the matter is your time is precious and better served working on other things. While putting together this submission may be your top priority, that does mean you have time to waste hunting down the latest FDA documents and ensuring the information people are sending you is up to date. Furthermore, it should not be your responsibility to then take these thousands of pages and attempt to use Microsoft Word to comply with the FDA’s mandated e-copy format.

On the topic of time-consuming tasks, it is worth talking about the RTA checklist that is required at the end of each submission. This is a time-consuming document that appears after you just spent countless hours compiling and formatting your entire application. Our software will automatically tell you which parts of this checklist apply to your device. Then, it provides a convenient function that allows you to answer the questions as you complete the section instead of at the end of the process.

We can’t perform most of the leg work for you but we will make it easier to compile and organize what you do collect. We also make sure you are not wasting your time worrying whether or not what you are submitting will be rejected by the FDA. The time we save you can be better spent tending to your other tasks and responsibilities.


Submitting a 510(k) application is a complex process that requires the help of an experienced expert. The sheer size of this project leaves most people open to errors and mistakes that result in being rejected. Our program has identified these common areas of mistake and provides solutions to ensure that they do not happen to you. Together, we can submit a 510(k) application that you can feel confident will be approved by the FDA.

About Essenvia

Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.

Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510(k) submission.

510(k) submission

The Top 5 Reasons The FDA Rejects A 510(k) Submission

If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes. You spend hours and hours collecting data and documents from various departments. You then spend more time finding the right templates and trying to understand the FDA’s guidelines. Plus, you have to search for the most up-to-date templates to use. After all of this hard work, the last thing you want is to discover the FDA has rejected your application.

Unfortunately, this is what happens to over 64% of 510(k) applications submitted for FDA clearance. Over 30% of these applications are not even accepted for initial review. Having a worthy device and the content to back it up is not enough to achieve FDA clearance. In this post, we cover the 5 most common reasons a 510(k) gets flagged and to avoid it.

#1 – Using Incorrect Or Out of Date FDA Templates

There are several sections throughout your 510(k) submission that require you to use some type of FDA-issued form. These sections include your Medical Device User Fee Cover Sheet (From FDA 3601), CDRH Premarket Coversheet (Form 3514), Cover Letter, and Indications for Use (Form 3381). Each section requires you to use the latest FDA-approved template when submitting your application.

The FDA is regularly updating these templates which makes it increasingly difficult to keep yup. While using the wrong template may not result in an outright rejection, it does put your application at risk of leaving out key information. Essenvia’s 510k application builder will always supply you with the most up-to-date templates. This helps avoid wasting hours scouring the internet and hoping you found the right templates. Furthermore, you can submit your application in confidence and no longer worry about submitting an out-of-date template and missing key information.

#2 – Discrepancies In Information That Appears More Than Once

As we mentioned above, the quality of your device and the content you provide are only part of this complex process. The FDA is quite strict when it comes to consistency in the information you provide. For example, your Indication for Use Statement appears over 20 times in your application and the FDA requires it remains the same throughout. Even if the intent remains unchanged, your application will be flagged, paused, and possibly even rejected if the wording does not match up.

It may seem simple enough to pay extra special attention when repeating information throughout your application. However, what happens when something changes towards the end of your process? You are now forced to scan your entire document and manually make this change each time. With Essenvia, this tedious type of work is done for you. With our Changelock™ feature, once you make this change on one page, it cascades throughout your entire document. You no longer have to worry if you missed a section during your review.

#3 – Not Following The 510(k) Submission Refusal To Accept Checklist

As we mentioned earlier, over 30% of submissions are rejected before they are even reviewed by a real person. This is due to their failure to comply with the Refusal To Accept checklist. In simple terms, the RTA checklist is what the FDA uses to determine if your device meets the minimum threshold for review. This document proves that you are worthy of the FDA’s time and have a realistic shot of gaining clearance.

This checklist consists of 56 questions all about the content and information in each section of your application. If you want until the end to fill it out, you risk providing answers that are not consistent with what you provided earlier. It’s important to note that not every question applies to your device. Our application builder not only shows you which questions are applicable but allows you to answer them as you are putting your sections together.

#4 – Choosing The Incorrect Predicate Device For Your 510(k) Submission

As you may already be aware, the FDA requires all submissions to list a predicate device on their application. Essentially, it is your responsibility to select a device already on the market that is substantially equivalent to the device you are seeking approval for. This is one key way the FDA can determine if your device is safe and effective. You can review current devices and their information by searching the FDA’s medical device databases.

Your Indication of Use Statement must align with the predicate device you have chosen. Whatever you decide your device is going to do it must match up with what your predicate device already does. It is equally important that your device’s technological characteristics are similar to those of the predicate device you have chosen. To increase your chances of clearance, you can include a side-by-side comparison for the reviewer to examine.

#5 – Skipping Not Applicable Sections In Your 510(k) Submission

While a traditional 510(k) includes 20 sections, not every single one of them will apply to your device. This includes sections such as Class 3 Summary and Certification, Financial Certification or Disclosure Statement, Performance Testing (Bench and Clinical) Proposed Labeling, Biocompatibility, Sterilization, and Shelf Life, and Electromagnetic Compatibility and Electrical Safety. A common mistake made by first-time submitters is leaving these sections blank instead of using a standard not applicable statement.

Even if the section does not apply to you, you are still required to state that in writing. Our application builder software will auto-populate these sections with pre-approved statements. This allows you to move past these parts of the application and focus on those that are applicable and important.


As you can see, compiling the content and data is only half the battle. The FDA expects and requires you to follow various guidelines and procedures. These requirements are why investing in a support program like Essenvia will return a high ROI. Together, we can make sure you submit a rejection proof 510(k) application and that all of your hard work will be worth it.

About Essenvia

Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.

Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510k submission.