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BSI Netherlands now designated as NB for MDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

BSI Netherlands is the seventh Notified Body (NB) to be designated under the Medical Devices Regulation (MDR, 2017/745), providing an MDR ‘escape route’ for UK manufacturers who are currently using BSI UK as their NB for the Medical Devices Directive (MDD, 93/42/EEC).

If there is a no-deal Brexit on or before 31 January 2020, the new date set for the UK to leave the EU, BSI UK will no longer be recognized as an EU NB, and its clients’ CE certificates will no longer be valid in the EU27 countries. The designation of BSI Netherlands is therefore of utmost importance to BSI UK clients, as it will ease the transition to a EU27-based NB, which is essentlal for continued marketing of devices in those countries.

This latest designation is of even more significance, given that BSI UK accounts for around one in three device CE markings across the entire device sector, thus reducing the possibility that many of the devices concerned will be unavailable in the event of a no-deal Brexit.