CliniExperts

EU MDR IVDR Clinical Evaluation

CliniExperts is an India-based regulatory and compliance consultancy serving medical devices, IVDs and other healthcare products. It supports Indian licenses, quality systems, clinical investigations and international market access. Its global device work includes EU regulatory due diligence, MDR and IVDR compliance, clinical evaluation, technical documentation and regulatory planning for Europe, the UK and United States.

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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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EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel

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