The EU introduced a complete revamp of its medical device regulatory framework back in 2017. The new regulatory framework consists of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
The transition to MDR and IVDR has been extremely difficult for the industry. The MDR and IVDR have essentially created “too much work, with too little time to do it in, with too few Notified Bodies to conduct it.”
Finally recognising these difficulties, the European Commission has issued a much anticipated legislative proposal extending the MDR transitional periods and removing the MDR and IVDR sell-off dates.
In this short webinar, life sciences regulatory experts Xisca Borrás and Jamie Hatzel share their insight on what these changes mean for both the EU and UK markets, as well as explore some of the more open questions.
Topics covered include:
- The re-certification crisis
- Legislative proposal 2023/0005 (COD)
- Revised transitional deadlines
- Legacy certificate extension and reanimation
- Where’s the action on IVDR?
- What about developments in the UK?
Note: All information in the video was correct as of the time of recording – 24 January 2023