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