Second Finnish Notified Body To Be Designated Within Two Months Under The EU IVDR
With a population of just over 5.5 million, Finland represents just 1.2% of the EU’s total population. Its testing capacity under the EU's IVD Regulation, in terms of numbers of notified bodies, now appears proportionately bigger than that of any other country.
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In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.
Altered compliance timelines under the EU’s Medical Device and IVD Regulations give the sectors more time. But urgency remains for manufacturers to hire notified bodies to assess their products. Expanded capacity bandwidth is promised soon.
The number of notified bodies designated under the IVD Regulation has now crept up to 11 as the first Finnish designation is announced.