MDR and IVDR – Key changes
See BSI’s Peter Bowness, Technical Team Manager from the Medicinal and Biologics Team, discuss the new EU regulatory regime for medical devices.
This week’s Compliance Navigator blog post is the first of two video excerpts from a presentation delivered by Peter Bowness at the 2019 Med-Tech Innovation Expo in Birmingham, UK.
In this video, you will hear:
- A brief overview of some key changes brought about by the MDR and IVDR, including changes to rules governing classification, technical documentation and post-market requirements
- Outlines of some of the recent work of the Commission, including corrigenda for the new Regulations as well as various guidance documents covering UDI, certificates, legacy devices and more
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The Compliance Navigator blog is issued for information only. It does not constitute an official or agreed position of BSI Standards Ltd or of the BSI Notified Body. The views expressed are entirely those of the authors.
