How to get a European CE Mark for Medical Devices?

What is the CE Mark for Medical Devices?

To sell medical devices in the European Union (EU), you must obtain the CE mark for your product. The CE mark indicates that your medical device complies with applicable EU regulations and allows your product to be commercialized in all EU member states. As a legitimate medical device manufacturer, whether you outsource any or all components of the manufacturing process, you are responsible for maintaining regulatory compliance and ensuring that the product obtains the CE mark. In vitro diagnostic (IVD) medical device manufacturers must meet similar requirements for the European CE mark.

How to Obtain the European CE Mark for Your Medical Device

The CE mark is not a quality mark, but compliance with the EU Medical Device Regulation (MDR 2017/745) requires meeting specific performance, quality, safety, and efficacy standards for your product type. Experts at Shangtong Testing can help you obtain the CE mark for your medical device and start selling your product in the EU.

The Basic Process for Medical Device CE Certification Follows These Steps:

1. Determine if your product meets the definition of a medical device under the MDR.

2. Classify the device.

3. Implement a quality management system (if applicable to your device). Most companies use ISO 13485 to meet the requirements.

4. Prepare the CE mark technical file or design dossier.

5. Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and the MDR.

6. If you do not have a physical location in Europe, select and appoint a European Authorized Representative (EC REP) to act on your behalf within the EU.

7. Have a Notified Body audit your QMS and technical file/design dossier, unless your device is Class I, non-sterile, and has no measuring function.

8. Obtain the CE mark and ISO 13485 certificate from your Notified Body.

9. Prepare a Declaration of Conformity (DoC) declaring that your device complies with the MDR.

JJR Can Help You Obtain the CE Mark for Medical Devices in the EU

China JJR Laboratory has assisted hundreds of medical device manufacturers in achieving European CE compliance. Our services include:

1. Assisting with product classification

2. Verifying applicable standards and testing requirements

3. Compiling technical files or design dossiers, or reviewing your documentation

4. Reviewing existing marketing materials, labels, and user manuals for compliance and consistency

5. Verifying compliance with essential requirements

6. Preparing Clinical Evaluation Reports based on provided clinical data

7. Implementing, modifying, and maintaining quality systems that meet European and other international requirements (usually ISO 13485)

8. Providing European Authorized Representative services

9. Risk assessment and management (ISO 14971)

10. Developing vigilance and post-market surveillance procedures

Contact China JJR Laboratory to learn how we can help you obtain the CE mark for your medical device in Europe.

Frequently Asked Questions About the CE Mark for Medical Devices:

How long is the CE certificate valid?

Under the current system, CE certificates issued by Notified Bodies are generally valid for three years. The validity period for certain high-risk devices may be only one year. However, your CE certification status depends on maintaining your quality system certification.

Our device already has the CE mark. How does MDR 2017/745 affect us?

MDR came into full effect in May 2021. Certificates issued before the final implementation of MDR are valid for up to five years. However, all CE mark certifications issued before the new regulations came into force will automatically expire four years after the new regulations take effect.

Who will issue my CE mark certificate?

If your medical device is Class I (provided sterile or with a measuring function), IIa, IIb, or III, or if your IVD is Annex II, List A; Annex II, List B, or self-testing, you will receive a CE certificate issued by a Notified Body. Class I non-sterile, non-measuring devices, and general/other IVDs may be self-certified and do not require a Notified Body's CE certificate.

Will the name of the Notified Body appear on my product label?

Their name will not appear, but their four-digit NB number will be shown below the CE mark symbol on your label.

Will changing contract manufacturers affect my CE certification?

Yes, as this constitutes a change in critical suppliers. In this case, the legal manufacturer (i.e., the "owner" of the CE mark) will select a new contract manufacturer based on the criteria outlined in their quality system, which should detail how suppliers are qualified and continuously assessed.

The legal manufacturer must notify their Notified Body of this change and apply for an updated CE certificate. The Notified Body may require an on-site audit of the new contract manufacturer to issue an updated CE certificate.