The IVDR will replace the currently valid IVD Directive (98/79/EC) as of 26 May 2022. With the new IVDR, manufacturers will have to perform conformity assessments for considerably more products.
Dr. Wilma Hartung, Managing Director Medical Devices at TÜV Rheinland, sees a significant workload coming up for the Notified Bodies: Many manufacturers of in-vitro diagnostics have to be certified for the first time.
The European Association Medical devices of Notified Bodies (Team-NB) is also concerned. In a position paper published on 25 November 2020, the Team-NB states that Notified Bodies will only support compliance with the current deadlines if the following conditions are met by the end of 2020:
Furthermore, the difficulty to perform QMS audits on site due to Covid-19 is addressed. Team-NB requires a decision on the deadline by the end of 2020 if the conditions cannot be met.
TÜV Rheinland LGA Products GmbH: TÜV Rheinland: Notified Body for In-Vitro Diagnostics