Essenvia-CE-Mark-EU

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.

Vocabulary

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
GSPR for EU MDR and EU IVDR

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:

EU MDD 93/42/EECEU IVDD 98/79/EEC
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