CMC Medical Devices

EU MDR IVDR

CMC Medical Devices is a Spain-headquartered regulatory consultancy supporting medical device and IVD manufacturers entering European and international markets. Its EU work includes CE-marking support under the MDR and IVDR, regulatory consulting and European Authorised Representative services. The firm reviews technical and regulatory requirements, supports communication with authorities, and advises manufacturers through market-access and ongoing compliance activities.

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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