MDR Annex I: General Safety and Performance Requirements (GSPR): Compliance through evidence

Medical Device Regulation 2017/745 updates the legal framework for all medical devices intended to be placed on the Single European Market. In addition to several new requirements, the MDR includes a changed Annex I which is now called General Safety and Performance Requirements (GSPR) vs. Essential Requirements (ER) under MDD/AIMDD. This Annex I is the foundation of all Conformity Assessments performed under the MDR.

The new title emphasises the focus on safety and performance and, in conjunction with further requirements, poses a new challenge for manufacturers.

Compliance must be demonstrated through controlled documents in the form of documented evidence. Providing an understanding of the GSPRs in general and the routes available to manufacturers in order to comply with each of the requirements this session is designed to be viewed together with the other webinars on our testing day 19 May.

Date and time: Tuesday, 18 May 2021, 5.30 pm (CEST)

Your speaker: Martin Witte, Senior Director, Strategic Business Development

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