The European Commission has proposed a gradual roll-out of the new IVDR regulation on in vitro diagnostic medical devices in order to avoid any interruption in their supply. This is certainly the result of actions carried out by MedTech Europe with European bodies, but also with professional unions in each of their countries.
Health and Food Safety Commissioner Stella Kyriakides said: “The COVID-19 pandemic has shown how essential it is to be able to make accurate diagnoses and have a strong regulatory framework for IVDs. Shortages at this stage are unthinkable. The pandemic has also imposed unprecedented challenges on our IVD industry. With more time to prepare for the application of the new EU rules, we will ensure a continued supply of essential in vitro diagnostic medical devices to the market, without compromising safety. I call on all manufacturers to prepare as soon as possible for certification under the new regulations and not to wait until the end of the transition period. "
The proposal does not substantially change any requirements of the in vitro diagnostics (IVD) regulation, but only changes the transitional arrangements to allow for the gradual roll-out of the regulation.
Concretely, the new provisions - including the reinforced rules of vigilance and market surveillance - would apply on May 26, 2022 for all products.But IVDs already covered by a manufacturer’s certificate or declaration of conformity under the current directive, provided they have not undergone any substantial modification, will have a longer period to have them renewed.
More particularly:
Class D IVDs (at high risk, such as HIV or hepatitis tests or) would have until May 2025, Class C IVDs (medium risk) until May 2026 sterile (lower risk) B and class A IVDs until May 2027.They must nevertheless, during this period, continue to comply with the directive and not be significantly modified.
No changes are proposed for non-sterile Class A devices or for devices that are “new”, i.e. devices that do not have a Notified Body certificate or a declaration of conformity under the current Directive 98/79. /THIS. For these types of devices, the IVD regulation will therefore apply from May 26, 2022 as planned.
The proposal will now be submitted to the European Parliament and the Council for adoption. So this is only a first step.
find here the proposed text published on the website of the European Commission
