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European Commission unveils surprise amendment to In Vitro Diagnostics Regulation

The European Commission has responded to pressure from the medical devices industry and has proposed an amendment to the In Vitro Diagnostics Regulation (“IVDR”, Regulation 2017/746) to introduce amended transitional provisions before the IVDR comes fully into effect and to defer its application to in house devices.

The IVDR will replace the current Directive 98/79/EC, the In Vitro Diagnostics Directive (“IVDD”), from 26 May 2022. Currently only about 8% of in vitro diagnostic devices need Notified Body involvement before their placing on the market. Under the IVDR, however, around 80% of in vitro diagnostic devices will be under the control on Notified Bodies, many for the first time. 

The EC has acknowledged that there is, at present, a serious lack of capacity in the Notified Body sector, with only six Notified Bodies having been so  far designated under the Regulation, These are established in only three countries, Germany, the Netherlands and France, making the situation particularly acute for SMEs in other member states.  The Covid-19 pandemic has drawn resources away from competent authorities, manufacturers and other health institutions. Travel restrictions have also contributed to a situation where data collected by the Commission in the first half of 2021 has shown that member states will not be in a position to ensure the proper implementation of the IVDR from 26 May 2022. If not addressed this would result in a significant disruption in the supply of many in vitro diagnostic medical devices, both for health institutions and for the public.

The EC proposal is, therefore, for a short new Regulation extending the transitional periods for devices covered by notified body certificates.  In order to spread the number of devices that need to undergo a conformity assessment, given the limited notified body capacity while prioritising high risk devices, Article 110 of the IVDR is amended to provide a transitional period for existing higher risk class devices that is shorter than the one for existing lower risk class devices. The new transitional periods for devices that did not require notified body under the IVDR are:

  • 26 May 2025 for class D devices;
  • 26 May 2026 for class C devices;
  • 26 May 2027 for class B devices;
  • 26 May 2027 for class A devices placed on the market in a sterile condition.

At the same time, the existing transitional period for devices placed on the market pursuant to the IVDD is extended by one year to 26 May 2025.

In addition, since many hospitals have had to focus their recent efforts on responding to the Covid-19 pandemic, the Commission also proposes a transitional period for the requirements of in house devices, manufactured and used within the same institution so that in house devices, which are often essential to diagnose rare diseases, can continue to be developed in clinical laboratories.