The unprecedented challenges of the COVID-19 pandemic led the European Commission to issue a proposal for extending the transitional arrangements for the new In Vitro Diagnostic Medical Devices Regulation (IVDR).
After European Parliament’s approval and adoption, the existing transitional period for in vitro diagnostic medical devices covered by notified body certificates issued under Directive 98/79/EC should be extended by 1 year, until 26 May 2025. Additionally, devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body and for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body, may benefit from a grace period.
The length of the proposed transition periods depends on the type of device: higher risk devices such as class D and C would have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices, would have a transition period until May 2027, as follows:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile condition.
The proposed amendments will not delay the application of the IVDR to CE marked in vitro diagnostic medical devices that do not require the involvement of a notified body (i.e. class A non-sterile devices) and to ‘new’ in vitro diagnostics (i.e. those not covered by a certificate or declaration of conformity issued under Directive 98/79/EC). For these devices, the IVDR is envisaged to apply in full from 26 May 2022.
The proposal does not change any requirements of the IVDR in substance but only changes the transitional provisions to allow the IVDR’s progressive rollout. The date of application remains unchanged, so IVDR vigilance and Post-Market Surveillance (PMS) requirements apply from 26 May 2022 for all devices on the market under IVDD and IVDR.
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices (14.10.2021)