Clinical Evidence
Group dedicated to all things clinical evidence
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Rebecca joined the group
Clinical Evidence 4 days ago -
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Clinical Evidence 6 weeks ago -
Holly posted an update in the group
Clinical Evidence 2 months agoHappy Monday everyone! I saw this complimentary webinar for this week that I am particularly excited about as I am working through similar justifications currently. Its about leveraging clinical data collected in one region to support regulatory submissions in another region. Thought I would share – its Nov 20 at 10 AM EST!
Link here: …
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Great topic – thanks for sharing Holly!
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Jorabar joined the group
Clinical Evidence 2 months ago -
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Clinical Evidence 4 months ago -
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Clinical Evidence 5 months ago -
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Clinical Evidence 5 months ago -
Niki joined the group
Clinical Evidence 5 months ago -
Amie replied to the discussion Definition of "clinical investigation" in the forum Clinical Evidence 5 months ago
Reply to Definition of "clinical investigation"
Yes, for legacy devices, per MDCG 2023-7, a clinical investigation is not required providing there is “sufficient clinical data” – and that can be clinical data from any of the sources listed in Article 2(48), including equivalence (no contract required for legacy devices).
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