News about GMP/cGMP

02.12.2020

EC: Fifth Notified Body according to IVDR

The European Commission (EC) designated the German company TÜV Rheinland as a Notified Body under the In Vitro Diagnostics (IVDR) Regulation on 1 December 2020.

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: 

  • The tools for conducting conformity assessments (e.g. expert:in panels, relevant MDCG guidance documents for classification, performance evaluation etc.) must be available and ready for use.   
  • At least half of the currently existing Notified Bodies should be designated according to the IVDR. Currently, there are five Notified Bodies, but after 31 December 2020 there will be only four, due to the brexit, unless more are added.  

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. 


Sources: 

TÜV Rheinland LGA Products GmbH: TÜV Rheinland: Notified Body for In-Vitro Diagnostics 

EC: NANDO 

Team-NB: Team-NB consideration paper on IVDR Date of Application 



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