Well, it's finally here. Yesterday marked the Date of Application of the European Union's new In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR), a revolutionary piece of legislation which (for better or worse) will have a tremendous impact on the MedTech industry in Europe.
There are some serious challenges: Notified Body capacity is still far below where it needs to be, and the guidance which is intended to help industry interpret the new rules under the IVDR has been slow to arrive and often unhelpful. 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.
We’ve written a number of articles in the last few weeks to explain the challenges – you can catch up on the “Spotlight on IVDR” series here:
- Spotlight on IVDR – Cheers Slovakia! Seventh Notified Body designated under IVDR
- Spotlight on IVDR – Why we keep banging on about Notified Bodies
- Spotlight on IVDR – Circumventing the Notified Body bottleneck
- Spotlight on IVDR – Will the European Commission blink?
- Spotlight on IVDR – The European Union’s new In Vitro Diagnostic Medical Device Regulation is here