RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2019 > 10 > EC Unveils First Notified Body Designation Under IVDR

EC Unveils First Notified Body Designation Under IVDR

Posted 10 October 2019 | By Zachary Brennan 

EC Unveils First Notified Body Designation Under IVDR

The European Commission (EC) on Thursday revealed that Germany-based Dekra Certification GmbH is the first notified body (NB) to be designated under the EU’s In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022.

The designation, which follows Dekra’s previous designation as the third NB under the Medical Devices Regulation (MDR) in August, comes as experts have warned that there may be a shortfall of IVDR-designated NBs. Similar concerns have been raised for NBs designated under MDR, which takes effect next May.

According to MedTech Europe, 11 NBs under IVDR (compared to 40 under MDR) have sent completed applications to the EC’s DG Sante, and only six have had on-site inspections. But the industry group also said it expects three additional NB notifications for both MDR and IVDR by mid-November.

And by the end of 2019, the EC is forecasting about 20 NB designations for both IVDR and MDR.




© 2022 Regulatory Affairs Professionals Society.