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Commission updates MDR Notified Body status

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has made available on its website a short PowerPoint presentation advising on the latest state of play with regard to the assessment of Notified Bodies under the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746).

The presentation, available from here, advises that 51 applications have now been received, 41 for the MDR and 10 for the IVDR. Preliminary assessment reports have been completed for 40 applications, with 17 CAPA plans being received.

The MDCG has recommended 4 new Notified Bodies to be designated, but the NANDO database has not yet been updated to identify which Notified Bodies are concerned.

In addition, the presentation reports that a further 5 Notified Bodies have had final opinions from the Joint Assessment Team, but these have not yet been reviewed and endorsed by the MDCG.

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