Do you always need a clinical investigation for your class III or implantable medical device?

​​​​About Event

​​​​Link to join the event:

​​​​👉 https://ro.am/r/#/p/2N9f_R0CTxOeiGrFh8TMug/KTT-kHh4hPXNgdfts1Mm7A

​​🎙 Do you always need a clinical investigation for your class III or implantable medical device?

​​📅 October 30th at 1:00 PM CET

​Clinical investigations are mandatory under MDR — but there are four exemption cases where they can be avoided, saving you significant time, money, and effort.

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​​Join us for a live session with Hatem, Clinical Evaluation Expert for Medical Devices from CEN, as he breaks down Article 61 MDR and key MDCG guidance to help you understand when a clinical investigation is (and isn’t) required.

​​You’ll learn:

​✅ The four exemption cases under MDR where a clinical investigation can be avoided

​✅ What “sufficient access to data” really means — and when a formal contract is required

​✅ The difference between equivalence based on your own devices vs. another manufacturer’s

​✅ Practical examples of how startups can leverage exemptions without risking compliance

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​👩‍⚕️ Whether you’re a QARA engineer, startup founder, or C-suite executive navigating MDR requirements, this webinar will give you clarity on a critical regulatory question.

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​💡 Bring your questions — we’ll close with a live Q&A on clinical evaluations and equivalence challenges.