Essentials of European Medical Device Regulatory Affairs - October 2019

Clinical Investigation Under MDD follow ISO 14155 : 2011 Clinical Investigation of medical devices for human subjects – Good Clinical Practice this has now been incorporated into the MDR – Protocol – Gather sufficient evidence to evaluate device – Record all AEs – Under the responsibility of a clinician – Final report should conclude with a critical evaluation

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Clinical Investigation Application _MDD • Application to CA (60 day review) and to ethics  committee • Key components of the application: – Investigator ´ s Brochure

– Clinical Investigation Plan / Protocol – Assurance of conformity with Essential  Requirements – Intended device labelling – Patient information sheet – Informed consent form – Qualifications of clinical investigator – Annex 10 declaration

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