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Two more Notified Bodies designated under the MDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

News from the European Commission and NANDO website is that an additional two Notified Bodies (NBs) have now been designated under the Medical Devices Regulation (MDR, 2017/745), but only one of these has yet appeared on the NANDO website.

DEKRA Germany has become the third NB designated under the MDR, with an entry on the NANDO website on 14 August 2019. The fourth NB to be designated is expected to be IMQ, Italy, with entry to the NANDO list within the next few days. These two will join BSI UK and TUV Sud who are already on the NANDO list.

Of course, designation is only the first step towards having NBs that are fully functional under the MDR, so we await information from all of those designated when they will actually be ‘open for business’ under the new Regulation.

While the doubling of the number of NBs designated for the MDR is good news, the bad news is that with only nine months to go before the Regulation takes full effect, only four NBs have so far been designated. Despite the painfully slow progress in adding NBs to the NANDO list, the European Commission still insists that the Regulation will take effect as planned, with no contingencies. The Commission reports that 52 NB applications have been received and 33 joint assessments have been carried out to date.

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