And then there were 10: Norwegian notified body wins EU MDR stamp

Dive Brief:

  • Norwegian firm DNV GL Presafe AG is the 10th notified body certified by the European Union under the forthcoming Medical Device Regulation, as the clock ticks down on the new rule going into effect May 26 of this year.
  • The update in the NANDO database comes after the European Commission teased last month that three more of the independent entities that certify medical devices and in vitro diagnostics in the now 27-nation bloc would win certification soon.
  • The new designation also comes days after U.K. formally left the EU, throwing uncertainty into how British companies fit into the new regulatory scheme.

Dive Insight:

The tally now stands at 10 notified bodies cleared to certify medical devices, with three entities getting the OK to operate under the parallel in vitro diagnostics regulation, which goes into effect two years later.

The other nine notified bodies authorized for MDR work are BSI (U.K. and Netherlands), Dekra (Netherlands and Germany), TÜV Rheinland (Germany), TÜV SÜD (Germany), Medcert (Germany), IMQ (Italy), and Dare!! Services (Netherlands). Currently designated IVDR notified bodies are BSI (U.K. and Netherlands) and Dekra (Germany).

It’s still far short of one Commission official’s earlier prediction that 20 would be certified by the end of last year. Industry has been pleading for a delay or speeding up in the process for more than a year, to little effect.

In an update late last month, the EC indicated it had received applications for MDR designations from 44 notified bodies, meaning it’s on track to ultimately certify most of the currently authorized groups to assess devices under the new rules. Half of the current in vitro diagnostic notified bodies have submitted applications, in addition to one application from a newcomer.

As for the Brexit factor, the U.K. remains subject to EU law until the end of the year during a transition period.

In theory, the U.K. could unilaterally stop applying MDR rules after the transition period ends. In the case of IVDR, the U.K. never needs to adopt the rules at all as they are due take effect after it leaves the EU. However, Prime Minister Boris Johnson and his predecessor have noted a desire to retain aspects of EU life sciences law, most explicitly in its no-deal preparations.


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