The unprecedented challenges posed by the COVID-19 pandemic have diverted the resources of Member States, health institutions, and economic operators towards the resolution of the crisis. This has hampered compliance within the timelines with the introduced changes. In addition, the number of notified bodies under Regulation (EU) 2017/746 is proving insufficient to allow the manufacturer to carry out the conformity assessment procedures required by law on time.
For this reason, the European Commission has proposed a gradual implementation of the new regulation on in vitro diagnostic medical devices in order to avoid any potential disruption in the supply of these essential health products. This proposal does not change the requirements of Regulation (EU) 2017/746 in any substantial way.
The length of the proposed transition periods depends on the type of device: Class D devices and certain Class C devices would benefit from a transition period until May 2025 and 2026, while low-risk devices (class B and A) would benefit from a transition period until May 2027.
No changes are proposed for CE-marked devices that do not require a Notified Body intervention under Regulation (EU) 2017/746 or for “new” devices, i.e., devices that have neither a Notified Body certificate nor a Declaration of Conformity under the current Directive 98/79/EC and are not subject to a significant change in design or use. For these types of devices, Regulation (EU) 2017/746 will therefore apply from 26 May 2022 as planned.
The European Commission’s proposal will now be submitted to the European Parliament and the Council for adoption.
Read more: Summary of the process | Q&A
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