Sequence Group LLC

FDA EU MDR

Sequence Group LLC is a Fort Lauderdale medical device consulting firm founded in 2023. Its team supports US regulatory submissions including 510(k) and PMA filings, EU MDR implementation and worldwide registration strategies. The firm's broader services span medical device development, software, ISO 13485 quality systems, FDA inspection readiness, risk management and post-market activities such as clinical follow-up and periodic safety reporting.

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Dr. Oliver Eidel

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Dr. Oliver Eidel

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Do distributors need to register in EUDAMED under MDR?

Anonymous · 1 comment

6 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