The European Commission proposes a “progressive roll-out” of the Regulation (EU) 2017/746 (IVDR)
The European Commission has proposed a progressive roll-out of the Regulation (EU) 2017/746 (IVDR) to prevent disruption in the supply of these essential healthcare products. The proposal is due to the unprecedented challenges of the COVID-19 pandemic to be faced by Member States, health institutions and economic operators. The EU staff members think that with more time available to prepare for the application of the IVDR a continuous supply of essential IVDs on the market can be ensured, without compromising on safety.
The IVDR was planned to fully apply as from 26 May 2022. However, today there is a serious shortage of notified body capacity, making it impossible for manufacturers to conduct the legally required conformity assessment procedures in time.
The newly proposed transitional provisions are dependent on the type of device: higher risk devices such as class D and class C have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices have a transition period until May 2027.
The Commission also proposes a deferred application of the requirements for devices manufactured and used within the same health institution (‘in-house devices’).
No change is proposed and thus will be implemented for IVDs that do not require notified body involvement under the IVDR (i.e. the Class A non-sterile devices). For those types of devices, the IVDR will therefore apply from 26 May 2022.
Moreover, there will be no delayed application for those devices that have neither a notified body certificate nor a declaration of conformity issued under the current Directive 98/79/EC (those that can be considered “new devices”).
The Proposal will now go to the European Parliament and Council for adoption.
The European Commission also published the document “Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation”. The document explains both the reasons why the proposal will be presented to the EU Parliament and the main changes in the IVDR application provided in the proposal.
Written by: Daniele Scarpino
Foto di Xaara Novack da Pixabay
