The Medical Device Regulation 2017/745 (MDR) was published on the official European Commission journal in 2017 and was intended to be fully implemented on May 26th, 2020. However, the 2020 Covid-19 pandemic meant this implementation was delayed until May 26th, 2021. This delay has also made the MDR’s date of the application later than Brexit on Dec 31st, 2020. Thus, the MDR is not implemented in England, Scotland, and Wales automatically.
As the transition period ended and MDR came into full implementation last month, no more certification under Directives 90/385/EEC and 93/42/EEC is to be issued. Devices on market with certification under Directives 90/385/EEC and 93/42/EEC (legacy devices), however, do remain valid until their MDD Certificates’ expiry date or May 26th, 2024 (whichever comes early), with a sell-off period until May 26th, 2025. These legacy devices shall still comply with MDR requirements on post-market surveillance, market surveillance, vigilance, registration of economic operators, and of devices.
The transition period proved to be a tough time for various parties to catch up with the requirements on time and remain compliant. BSI was the first MDR-certified notified body and issued the first MDR certification in 2019 (Novartis Concept1 inhaler, Class IIa device). Post that, as many as 20 notify bodies have been designated as MDR-certified NB. The full list of certified NBs can be found at this link.
To enable manufacturers and other economic operators to fully comply with MDR regulations, the Medical Device Coordination Group (MDCG) has published a series of guidance documents on several aspects of the MDR, including clinical investigation and evaluation, custom-made devices, newly introduced medical device database EUDAMED, unique device identifier (UDI), etc. The full list of MDCG guidance can be consulted at this link.
As it is a huge transition from MDD/AIMDD to MDR, there are still some parts of the MDR that would be unraveled in the near future, such as the full list of Common specifications and implementation of the EUDAMED. The European Commission has provided a rolling plan for these unrevealed requirements at this link.