The EU Regulation on in vitro diagnostic medical devices (Regulation 2017/746) was due to come into force on 26 May 2022. The European Commission has estimated, however, that Member States will not be ready to meet the requirements of this regulation in time, and so the Commission has therefore finally agreed to grant a reprieve to the EU-27.
On Thursday 14 October, the institution adopted a proposal in which it set out a progressive implementation of the regulation. More specifically, it proposes to extend the transition periods for some types of schemes.
Nothing will change, for example, for devices that do not require the intervention of a notified body (non-sterile Class A devices, which represent about 20% of the market) for ‘new’ devices, i.e. those that are not covered by a certificate or a declaration of conformity from the manufacturer that was issued before 26 May 2022.
However, for high-risk devices, such as HIV or hepatitis tests (class D) and some influenza tests (class C), the transition period will end in May 2025 and May 2026, and will end in May 2027 for low-risk devices, such as class B and A sterile devices.
The European Commission had already taken similar steps in April 2020 in respect of the new Medical Devices Regulation (2017/745 - see EUROPE 12461/8). As was the case in April 2020, it has justified its decision by citing “the unprecedented challenges posed by the Covid-19 pandemic”.
It “demanded a reallocation of resources from Member States, health care institutions and economic operators to address the crisis”, she said, adding that “the capacities of notified bodies are hugely insufficient, meaning manufacturers are unable to carry out the legal conformity assessment procedures” for medical devices in time.
The Commission’s proposal will now be submitted to the European Parliament and the EU Council for adoption.
To consult the proposal: https://bit.ly/2Xf9Nda (Original version in French by Agathe Cherki)