Is additional registration required in France for MDR Class I device already registered in Germany?

Question

Our company is a non-EU manufacturer with an assigned EU Authorized Representative. Our MDR Class I medical device is already registered with the competent authority in Germany. Do we need to register or notify the authorities separately in any of the following countries if we plan to market the device there?
• France
• Italy
• Spain
• Netherlands
• Poland
• Sweden

Specifically, for France, is there any additional registration required if the product is already registered in another EU member state?

Dr. Oliver Eidel · Accepted Answer

For MDR Class I devices, registration requirements may vary between EU member states, even if you already have registration in one country. Based on shared experiences and available information:
• France: Yes, you must declare France as a country of marketing on Eudamed. If your device is not yet registered on Eudamed, you must make a declaration to the French competent authority.
• Italy: Yes, separate registration is required.
• Spain: Yes, separate registration is required.
• Netherlands: No additional registration is typically required, but it's best to verify with local experts.
• Poland: No additional registration is generally required.
• Sweden: No additional registration is generally required, but there are some reports that you may need to register with the Swedish Medical Products Agency. Check the latest guidance.

The requirements may also depend on whether your device is registered in Eudamed. Always check with the local competent authority or a regulatory expert for the most current requirements.

Is additional registration required in France for MDR Class I device already registered in Germany?

1 Answer

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