IVDR mandatory from today


From 27.05.2022, 00:00, the application of the IVD Medical Device Regulation (IVDR) (EU) 2017/746 is mandatory!

Our first open training on IVDR was held on 01.06.2017, when the 5-year transition period still seemed very long. Even then, the quantity and quality of the migration work was a cause for concern, but everyone thought that five years would be enough. At the time, of course, we never dreamed of the COVID-19 epidemic or that not only manufacturers were having difficulty adapting gearboxes, but that the EU was also very slow to comply with the tasks imposed on them by the regulation. Where are we now, when the original idea was that all the conditions should have been met:

  • Only 7 IVDR Notified Bodies have been designated, while the number of certificates to be issued is about four times higher than under the Directive.
  • Only 3 of the planned 6 EUDAMED modules are operational. According to the latest official information, EUDAMED will only be fully operational in the second quarter of 2023.
  • Only 11 harmonised standards have been published and no Common Specification has yet been issued.
  • Only 8 MDCG guidelines have been published in total, of which 5 were published this year.

In a Regulation published on 25 January 2022, the European Parliament and the Council extended the transitional period of the IVDR for devices covered by certificates issued in accordance with Directive 98/79/EC.

Thus, manufacturers will have to comply with the IVDR requirements during a transitional period until 26/05/2028, depending on the risk class. It is worth reiterating the requirements that are mandatory from today:

  • Class A non-sterile devices have not been granted any deferral. Manufacturers of these devices are now required to fully implement IVDR.
  • Newly developed devices are not covered by any moratorium. Therefore, for ongoing product developments, the conformity assessment procedure under the IVDR must already be carried out.
  • In fact, the IVDR has introduced the category of "legacy device", similar to the MDR, but we see that many people are ignoring an important aspect of the transitional provisions: "the requirements of this Regulation (IVDR) concerning post-market surveillance, market surveillance, vigilance and registration of operators and devices shall apply instead of the corresponding requirements of Directive 98/79/EC (IVDD)..." Thus, it was mandatory for all manufacturers to date to prepare and implement the IVDR's procedures for PMS activities, vigilance and registration.

So the full implementation of IVDR is still a long way off and there is still a lot of work to be done by both manufacturers and the EU authorities.