Mid-May MDCG Mandate Madness: Pre-empting Questions On Investigator Brochures

Designating Authority Checklists Also Published

Newly issued EU guidance documents make it easier for device companies to draft clinical investigation brochures that will pass authority inspection. They also give insight into what notified body designating authorities check for.

Clinical trial
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The Medical Device Coordination Group, the entity which supports the implementation of the Medical Device and IVD Regulations and oversees the drafting and adoption of guidance documents, published a series of new guidance documents during the first half of May.

The first was MDCG 2024-5: Guidance on content of the investigator brochure for clinical investigations of medical devices, a...

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