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Nexialist

EU MDR IVDR Clinical Evaluation

Nexialist is a regulatory intelligence and health-product compliance consultancy based in La Ciotat, France. It supports medical device and IVD manufacturers with regulatory strategy, CE marking, quality systems, technical documentation, design and development, audits, process validation, post-market surveillance and clinical evaluation. The multidisciplinary firm works across the device lifecycle and provides both consulting and regulatory training.

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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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Do IVDR Annex IX Chapter II certificates apply to Class C devices?

Anonymous · 1 comment
6 months ago
Our company received an EU Quality Management System Certificate (IVDR) for Annex IX Chapters I and III. We have a Class C device (not for self-testing, near patient testing, or companion diagnostic u
Accepted 1 answer

You won’t get a product-specific (Annex IX Chapter II) certificate for a Class C device. Those certificates are only issued for Class D devices. For