In Vitro Diagnostic Medical Devices Regulation (2017/746) – update on transition
On 20 December 2021, the European Commission reported that the In Vitro Diagnostic Medical Devices Regulation (IVDR) that will apply as from 26 May 2022, can be progressively rolled out, following its adoption by the European Parliament and Council, enabling the continued supply of essential in vitro diagnostic (IVD) medical devices and the protection of public health and safety.
The IVDR introduces a new mandatory regulatory framework for IVD medical devices (e.g. pregnancy tests, SARS-COV-2 tests), including:
- A new rule-based classification system, with four risk classes of IVD medical devices (class A to class D, with class D being the highest risk to individual and public health).
- Increased involvement of notified bodies which will be empowered to independently assess whether certain IVD medical devices comply with the requisite safety and performance requirements before release onto the EU market.
- More stringent post market surveillance requirements for manufacturers.
The proposal to progressively roll out the IVDR was made in October 2021 following long standing concerns raised by industry stakeholders that the implementation of the new regulation would be extremely challenging in light of a shortage of notified bodies and the deployment of resources due to the COVID-19 pandemic.
The adoption of the proposal means there will be additional transitional periods for devices that are required to undergo a conformity assessment by notified bodies for the first time under the IVDR, with a transition period until May 2025 for high risk devices (class D) and May 2027 for devices with the lowest risk (class B and A sterile).
The IVDR will still apply on 26 May 2022, and will apply in full from that date to CE marked IVD medical devices that do not require a conformity assessment by a notified body.