NEMIUS Medical Europe

EU MDR IVDR

NEMIUS Medical Europe is a Mainz-based consultancy specializing in medical devices and in vitro diagnostics. Its regulatory-affairs team supports manufacturers, importers and distributors with EU MDR and IVDR requirements and international registrations. Services include product qualification and classification, technical documentation, risk management, biocompatibility, sterilization planning, clinical evaluation and post-market activities. The firm also develops and improves quality management systems and supplies external regulatory functions.

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Recommendations for EU Notified Bodies for CE and MDR applications outside Germany

Anonymous · 1 comment

6 months ago

Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR certification within thi

Accepted 2 answers

A few months ago, Kiwa Dare in The Netherlands still had capacity to accept or at least discuss new customers, and they handle medical device software

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

Anonymous · 1 comment

8 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

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Registering Your UDI in EUDAMED (Medical Device Database)

Dr. Oliver Eidel

1 K views · 8 months ago