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NordMDR

EU MDR IVDR

NordMDR is a Stockholm-based regulatory consultancy serving medical device manufacturers entering or operating in Europe. It works particularly with small and mid-sized companies on EU MDR compliance, CE-marking strategy, technical documentation, EUDAMED registration and authorized representation. The practice also documents experience with IVDR requirements and post-market obligations. NordMDR provides fixed-scope regulatory assistance to manufacturers across the Nordic region and other non-EU markets.

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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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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

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Are EU MDR obligations triggered if an EU manufacturer sells via a distributor outside the EU?

Anonymous · 1 comment
6 months ago
Does the EU MDR place any obligations on an EU-based manufacturer if a product is sold outside the EU through a distributor? For example, if our company manufactures a device in the EU and sells it in
Accepted 2 answers

The MDR only applies to devices that are placed on the market, made available, or put into service within the EU. So, if you sell your product outside