In brief
On 28 January 2022 Regulation (EU) 2022/112 (“Regulation”) amending Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”) was published in the Official Journal of the EU.
Contents
Key Takeaways
In particular, the Regulation introduces longer transitional periods with respect both to the validity of certificates issued by notified bodies in accordance with Directive 98/79/EC (“IVDD”) and for the making available on the market and putting into service of in vitro diagnostic medical devices lawfully placed on the market pursuant to the same IVDD. Conversely, safety and performance requirements set forth in the IVDR and its application date, scheduled for 26 May 2022, remain unchanged.
