The European Union’s new In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) is here, a revolutionary piece of legislation which (for better or worse) will have a tremendous impact on the MedTech industry in Europe.
The predecessor In Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD) has now been repealed. The Notified Bodies which were designated under the IVDD to conduct conformity assessments on in vitro diagnostic medical devices (IVDs) are no longer competent to do so, unless they are among the tiny number of Notified Bodies which have been designated under the IVDR. Going forward, the entities involved in the IVD supply chain will have to comply with much more onerous obligations, and all new IVDs will have to undergo much more strenuous conformity assessment procedures before they can be marketed in the European Union. Existing IVDs which are compliant with the IVDD will be allowed to remain on the market for the time being under transitional provisions, but in due course they too will have to undergo conformity assessment under the IVDR.
Like many others in the MedTech sector, we have been keeping a close eye on industry preparedness as the IVDR Date of Application has approached. As expected, Notified Body capacity is still far below where it needs to be to perform the Conformity Assessments which are necessary just to keep existing IVDs on the market, and the guidance which is intended to help industry interpret the new rules under the IVDR has been slow to arrive and often unhelpful. Thanks to the IVDR transitional provisions, very little has changed overnight for existing IVDs, but there are some serious challenges ahead which may require regulators to take radical steps to preserve the availability of IVDs on the European market. It is difficult to predict exactly how the next few months and years will play out for the IVDR, but one thing is certain: there is change afoot.
Catch up on the Spotlight on IVDR series below, where we analysed the challenges posed by the IVDR and how regulators might respond to them: