Boulder iQ

FDA EU MDR IVDR Clinical Evaluation

Boulder iQ is a Colorado-based life-sciences consulting firm supporting medical devices, diagnostics and combination products from development through market entry. Its regulatory team prepares FDA 510(k), De Novo, IDE and PMA submissions and supports agency interactions, registration, audits and remediation. International services include EU MDR and IVDR transitions, CE-marking documentation, clinical evaluation reports and post-market surveillance.

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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

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

Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel