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Clinical Investigation Exemptions

Regulatory Strategy / Clin-r+

Do manufacturers need to conduct investigations or follow an exemption route? CLIN-r+ explores the exceptions as outlined by MDCG 2023 and MDCG 2020-6.

Clinical Investigation Exemptions Read More »

Clinical Investigation FAQ

What are clinical investigations according to the EU MDR?
Why is clinical data required? What types of clinical investigation can be conducted?

We have all the answers and more…

Clinical Investigation FAQ Read More »

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