In Vitro Diagnostic Medical Devices Regulation (2017/746) – update on transition
The IVDR has now entered into full application in the EU. Although the IVDR is an EU piece of legislation, UK companies looking to sell and market IVDs in the EU will need to ensure they comply with its provisions.
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance to assist manufacturers and suppliers of IVDRs in relation to how long ‘legacy devices’ – being those devices placed on the market prior to 26 May 2022 and those that are covered by a valid EC certificate in accordance with the previous IVD Directive (IVDD 98/79/EC) prior to 26 May 2022 – can remain on the market following the application of the IVDR.
The guidance also explains that Eudamed, the EU’s medtech database which is being developed to support the MDR and IVDR, will not be fully functional by 26 May 2022 and therefore it will not be mandatory or enforceable to use it until six months from the date that it has been confirmed to be fully functional. The MDCG has called for IVDR-specific guidance on harmonised administration practices and technical solutions to support businesses in the meantime.
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.