Obelis Group

EU MDR IVDR FDA

Obelis Group is a Brussels-based regulatory consultancy and in-country representation provider. For medical device and IVD manufacturers, it supports compliance and representation in the European Union, United Kingdom, Switzerland and United States. Services include MDR and IVDR technical-documentation review, registrations, authorised representation, vigilance and regulatory maintenance for manufacturers entering or remaining in these markets.

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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

3:06

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Dr. Oliver Eidel

103 views · over 2 years ago

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