Essentials of European Medical Device Regulatory Affairs - October 2019

Adverse event reporting Record • AEs critical to the evaluation • SAEs • Device deficiencies that might have led to an SAE • Relevant new findings Report to all concerned MS (via portal) • SAE causally related to the device, comparator or procedure • Device deficiency that might have led to SAE • Events in non EU countries involved in the CI Timeline • Without delay: an initial to allow that and follow up report

If a PMCF investigation follow marketed product reporting rules

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Documents. Annex XV. Chapter II

1.Application form

Items in red: each MS will review. Article 78(3)

1.1Sponsor details, or legal rep in EU

1.2manufacturer and Authorised Rep

1.3and 1.4protocoltitle, status (i.e. initial, amendment)

1.5 reference to the clinical evaluation plan

1.6explain changes if not initial application

1.7 if in parallel to amedicinal product application provide Eudractnumber

1.8 Identify all countries (EUand non EU) involved

1.9description of the device and its classification

1.10 information if device includes amedicinal product orother items e.g. nonviable tissues 

1.11 summary of the clinical investigation plan (objectives, number and gender, age of subjects) design (controlled) planned dates  (startand completion.)

1.12 information on comparatordevice

1.13evidence that the clinical investigator and site are capable of conduction the investigation