Module 3 - Strategic case studies in practice

Annex 1: Proposal for Notified Body Opinion template 733

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NB logo

NB name and address

NB number

Notified Body Opinion

(Article 117 of the Medical Device Regulation (EU 2017/745)

Compliance of device(s) incorporated into an integral drug-device combination product

with

Annex I (General Safety and Performance Requirements)

Medical Device Regulation (EU 2017/745) 746 747 748 749 750 751 Administrative reference number: ________________________________________________________ 752 (including version number)

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Reviewer name and position:

________________________________________________________

NB authorisation (signature): 758 759 Authorisation date (YYYY/MM/DD) ________________________________________________________ ________________________________________________________

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Guideline on the quality requirements for drug-device combinations

EMA/CHMP/QWP/BWP/259165/2019

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