The very strict timing to reach compliance to the new requirements established by regulation (EU) 2017/745 (MDR), with the transition period ending 26 May 2024, poses many challenges to manufacturers of medical devices called to obtain a new certification for their products. The concrete risk is that many devices may be discontinued, thus leaving patients and healthcare professionals without the tools needed to treat many health conditions. To answer this urgent issue, the European Commission published on 6 January 2023 a proposal amending article 120(3) of the MDR regulation, so to extend the transition period for “legacy” devices which had obtained certification or a declaration of compliance before 26 May 2021, according to the requirements of the previous directives 90/385/EEC o 93/42/EEC.
The proposed date for the new end of the transition period for higher risk class III and class IIb implantable devices would be 31 December 2027, while for medium and lower risk devices (classes IIb, IIa, Im, Is and Ir) the term would be postponed up to 31 December 2028. Class III custom-made implantable devices would benefit of a transition period up to 26 May 2026; those devices are currently not covered by the Regulation’s transitional provisions. The possibility to extend the transition period would be subject to several cumulative conditions, among which are considerations on the safety of the devices and the requirement manufacturers had already taken steps to transition to the MDR Regulation.