Medtech Insight

Second Finnish Notified Body To Be Designated Within Two Months Under The EU IVDR

31 Oct 2023

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.

Flag of Finland flies against a blue sky

Sertio Oy, based in Tampere, Finland, has become the 12th EU notified body to be designated in the context of the IVD Regulation, and the second in Finland.

It is a new notified body, formally recognized in July this year. Despite this, and not having been named under...