OPENREGULATORY
Sign in Get started
Ask a question
Getting Started 1 answer

Is EUDAMED registration mandatory for economic operators in Germany?

Anonymous · Published February 26, 2026 · 1 comment
I understand from MDCG 2022-12 and Article 28 that EUDAMED registration is voluntary unless a member state requires otherwise. In Germany, it appears that registration in EUDAMED is mandatory for economic operators, such as authorized representatives (AR) located in Germany.
Can anyone clarify if EUDAMED registration is indeed mandatory for manufacturers and ARs based in Germany? If so, what is the official source for this requirement?

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

Anonymous 3 months ago
Can you share your source for the mandatory EUDAMED registration in Germany? I thought registration was still with local authorities, even for MDR devices.
 Reply to this comment

Discussion

1 Answer

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
You can find the information on the website of the German Competent Authority BfArM, specifically under the section 'Anzeigen von Medizinprodukten': https://www.bfarm.de/DE/Medizinprodukte/Ueberblick/Europa-und-EUDAMED/_node.html
The section refers to the official publication from May 28, 2021: https://www.bundesanzeiger.de/pub/de/amtliche-veroeffentlichung?3 (see chapter II). This publication outlines the requirements for EUDAMED registration for economic operators in Germany.

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

No comments yet. Be the first to share your thoughts.
Want to add your answer to this question?
Write an answer under your name by logging in or signing up, or post anonymously.

Keep reading

All questions
A

Do distributors need to register in EUDAMED under MDR?

Anonymous · 1 comment
4 months ago
I am seeking clarification regarding the registration requirements for economic operators in EUDAMED under the Medical Device Regulation (MDR). Specifically, do distributors (as defined in MDR Article
Accepted 1 answer

Distributors do not need to register in EUDAMED. Only manufacturers, importers, and authorized representatives are required to register according to A

A

Are distributors required to register in EUDAMED under MDR?

Anonymous · 1 comment
4 months ago
We are reviewing the requirements for economic operators and their registration in EUDAMED. Specifically, do distributors (as defined in MDR Article 14) have to register in EUDAMED? According to MDR A
Accepted 1 answer

Distributors don't need to register in EUDAMED. Only manufacturers, importers, and authorized representatives are required to register. The system cur

A

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

Anonymous · 1 comment
6 months ago
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
Accepted 1 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 s

Still have a question? Ask a question here publicly — for free.

Or talk to one of our consultants — first calls are free. Check out our services and prices.

Looking to automate your regulatory work? Check out our eQMS, Formwork. Built for lean, founder-led companies. There’s a free version too.