The CE Mark Certification for Medical Devices

What is CE certification for medical devices?

Medical devices need to conform to the legislation of the region of their target market. This means that the device may be subject to clinical trials and other approval processes with relevant regulatory bodies. Once conformity has been certified, the device can be placed on the market.

In the EU, medical devices with a CE Mark have demonstrated conformity to the legislation for medical devices in the EU. Specifically, the CE Mark indicates that the medical device has conformed to all applicable requirements of the EU Medical Device Regulation.

How do I get a CE mark for my medical device?

There are seven stages in the process for you to get a CE mark for your medical device:

  • Classify your device in terms of its risk class

    • Your device will be classified as either Class I, Class IIa, Class IIb, or Class III, according to its associated risks.

  • Identify requirements that apply to your device

    • Use the risk class to identify exactly which requirements from the MDR apply to your device, including which EU harmonised standards and other health and safety legislation applies.

  • Compile the Technical Documentation

    • The technical file should include: product description and specifications, manufacturing information, risk management file, design verification and validation test reports, clinical evaluation, labelling and a description of the design process for the device (for Class III devices only).

  • Appoint a European Authorized Representative

    • If you do not have a registered address in the EU, you must appoint a European Authorized Representative (EAR).

  • Get the device independently assessed (only applies to risk classes 1s, 1m, 1r, IIa, IIb, III)

    • For certain risk classes, a Notified Body must perform an audit to confirm conformity.

    • The audit will cover all applicable requirements of the MDR, including, e.g., and audit of the quality management process.

  • Create a Declaration of Conformity (DoC)

    • The DoC is a legally binding document which declares that your device conforms to all essential requirements as stipulated by the EU MDR and by any other applicable regulatory standards.

  • Attach the CE Mark

    • The CE Mark must be clearly displayed on your device, its user documentation, and its packaging.

Please note: The process defined above does not describe the details of the quality management process which is assumed to already be in place.

Do medical devices need a CE mark?

It is mandatory that all medical devices targeted for the EU market need a CE mark.

Which countries require a CE mark for medical devices?

A CE mark is only mandatory for all countries in the European Economic Area.

There are some countries that accept devices with a CE mark to be placed on their markets, e.g. Switzerland and Serbia, but they may still have other compliance requirements for the device.

How long does it take to get a CE mark?

With the EU MDR only in force since 26 May 2021, there isn’t enough data to get a good idea of how long it will take to get a CE mark. Ultimately, it depends on the complexity of the device, the risk class and the level of evidence that is required in order to demonstrate safety and reliability of the device.

Who can issue CE mark certification?

CE mark certification is performed by so-called “Notified Bodies”.

For more information on Notified Bodies and for how to find a Notified Body to assess your medical device, please refer to the glossary entry on Notified Bodies.

What is the difference between FDA Clearance and CE certification?

FDA clearance applies to medical devices that will be put onto the US market, while CE certification applies to medical devices that will be put onto the EU market.

If you would like more information on the CE Mark for Medical Devices, please contact us at regulations@arrowfast.tech. Our team of experts would be happy to help you.

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