Johner Institute

EU MDR IVDR FDA

The Johner Institute is a German consulting and training institute for medical device regulatory affairs, based in Konstanz. It supports manufacturers with EU MDR and IVDR approvals as well as FDA market access, and is well known for its training offerings and freely available regulatory guides and templates.

Learn more

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

Free MDR Templates

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