Europe – TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

The European Commission (EC) has announced designation of a fifth notified body for the European Union In Vitro Diagnostic Regulation (IVDR). TÜV Rheinland, the new notified body, was also designated a notified body for the upcoming Medical Device Regulation (MDR) in 2019. (Related: TÜV Rheinland becomes 5th notified body designated under MDR, Regulatory Focus 26 September 2019)
 
Implementation of MDR has been delayed by a year to May 2021 because of concerns about pandemic-related delays, but to date the IVDR deadline has stayed firm, with full implementation slated for May 2022; a grace period for devices with a valid IVDD certificate stretches to May 2024.
 
Though just 5 notified bodies have been designated for IVDR, a total of 15 applications had been received by EC by the end of October 2020. Most applicants are still in the early phases of assessment and review, however…