S3E6 - IVDR: what is at stake for IVD manufacturers and for the laboratories?
Welcome to Ask Stago, The Podcast dedicated to provide expert answers to your expert questions in coagulation.
In today’s episode, our guest Sophie Réhault will give us explanations on what is the new EU IVD regulation and what it implies both for IVD manufacturers and for the clinical laboratories.
Link to previous podcasts:
- S2E18 – Practical check list of the implementation of an instrument in your lab:https://www.podcastics.com/podcast/episode/s2e18-practical-check-list-of-the-implementation-of-an-instrument-in-your-lab-103649/
- S3E4 – All you need to know about instrument validation: https://www.podcastics.com/podcast/episode/s3e4-all-you-need-to-know-about-instrument-vlalidation-120105/
Literature sources:
- Regulation (EU) 2017/746 (IVDR) of the Europan Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and commission Decision 2010/227/EU
- European Parliament Legislative resolution of 15 December 2021 on te proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in house devices (COM(2021) 0627-C9-0381/2021 – 2021/0323 (COD))
Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.