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Twenty NBs now designated for MDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

Eurofins Expert Services Oy, located in Finland, has become the twentieth Notified Body (NB) to be designated under the EU Medical Device Regulation (MDR, 2017/745) according to the NANDO database.

Eurofins is Notified Body number 0537 and remains designated under the Medical Device Directive (MDD, 93/42/EEC) and In Vitro Diagnostics Directive (IVDD, 98/79/EC).

The European Commission has now met the NB MDR number target it set for itself, but over one year later than it originally estimated.

The number of IVDR NBs remains at four, although the Commission is optimistic that, as reported last month, one further NB for each Regulation will be announced before the end of April. A further 30 NBs for the MDR and 10 for the IVDR are currently undergoing the designation process, according to the Commission.

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