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Thema

EU MDR IVDR

Thema is a quality and regulatory affairs consultancy for medical devices and IVDs based in Imola, Italy. It supports manufacturers and distributors with strategic regulatory advice, CE-certification projects, compliance with the EU MDR and IVDR, Italian and European registrations, international registrations outside the EU, local representation, quality systems and good manufacturing practice requirements.

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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

Registering Your UDI in EUDAMED (Medical Device Database) 15:16

Registering Your UDI in EUDAMED (Medical Device Database)

Dr. Oliver Eidel

1 K views · 8 months ago
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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