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New Notified Bodies appear on NANDO website

  • Posted by: inetika
  • Category: GLOBAL NEWS

18 Notified Bodies are now listed on the NANDO website for medical devices falling under the Medical Device Regulation (MDR, 2017/745) and 5 are now listed for the In Vitro Diagnostics Regulation (IVDR, 2017/746).

These numbers are still well short of the number needed to cope with the anticipated influx of requests to Notified Bodies over the next 2 or 3 years, however, as existing MDD/IVDD quality system certificates expire.

New to the NANDO lists are UDEM Adriatic d.o.o., Croatia, NB no 2696, for the MDR, and TÜV Rheinland LGA Products GmbH, Germany, NB no 0197, for the IVDR.

On 31 December 2020, however, each list will lose BSI UK, NB no 0086, because it will no longer be able to act as an EU Notified Body after Brexit.