Scandinavian Regulatory Services

EU MDR IVDR FDA

Scandinavian Regulatory Services is a Swedish quality and regulatory consultancy founded in 1992. Its medical device team supports products from development through the full device and IVD lifecycle, including MDR and IVDR implementation, regulatory strategy, technical files, post-market work and ISO 13485 quality systems. The firm also advises on US 21 CFR 820 requirements and works with medical-device software and combination products.

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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

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

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