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

Question

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 this year. We previously registered with TÜV SÜD in Munich and planned to submit for ISO 13485 in September 2022, but they recently informed us they lack the resources to provide the service. This was the last Notified Body in Germany we tried; others rejected us due to a lack of resources for 2022/2023. Does anyone have suggestions for Notified Bodies in other EU countries with available capacity?

Dr. Oliver Eidel · Accepted Answer

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 well. It's worth reaching out to them to see if they still have availability.

Answer

You could also try Berlincert, depending on your device scope. They can support you with ISO 13485 audits, although they are not yet accredited under MDR but are expected to be around March. A 13485 audit is always possible.

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

2 Answers

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