EU notified body technical documentation reviews

European Authorized Representation for Manufacturers of Medical Devices mdi Europa - EU flags in front of EU parliamentEuropean Authorized Representation for Manufacturers of Medical Devices mdi Europa - EU flags in front of EU parliament

The notified body association, TEAM-NB, has issued a position paper, Best Practice Guidance for the Submission of Technical Documentation under Annex II and III Medical Device Regulation (EU) 2017/745. The paper intends to lay out what is needed in a technical documentation submission and advises a framework for using evidence from assessments under the medical devices directives. 

The approach that is described in the position paper has been partly made possible by the MDCG 2022-14 position paper in which the Medical Device Coordination Group (MDCG) recommended a 19-point plan to, among others, boost notified body capacity. One recommendation for notified bodies was to develop a framework for using evidence from earlier assessments under the directives.

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