Eisner Safety Consultants

FDA EU MDR

Eisner Safety Consultants is a US practice founded and led by product-safety and regulatory consultant Leo Eisner. Its work centers on active medical electrical equipment and the IEC 60601 series, alongside risk management, labeling, software lifecycle and technical documentation. The practice and its associates support global market access activities including FDA 510(k) submissions, EU MDR compliance and UKCA marking.

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Free MDR Templates

Dr. Oliver Eidel

103 views · over 2 years ago

12:18

Vigilance For EU MDR and ISO 13485 Compliance

Dr. Oliver Eidel

16 views · 9 months ago

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