26 May 2021: the final countdown has finished and after a one-year postponement the Medical Devices Regulation (MDR) must now be applied.
After a short break of relief, manufacturers of medical devices sold in the EU will have to comply with the requirements of the MDR from 26 May 2021.
The delay in application has been used to provide greater clarity for unclear aspects of the MDR:
- Many guidance documents, including for UDI, have been released during recent months.
- Early in 2021 a notice was released which anticipates the conditions under which remote audits can be conducted due to difficulties with on-site audits caused by COVID-19.
- Although full functioning of EUDAMED is delayed by two years until May 2022, economic operators have the possibility to register as an Actor for a single registration number (SRN). The plan is that the UDI module goes live in September 2021.
- In February 2021 a notice was published on how to register legacy devices certified under former legislation and still legally on the market.
- In addition to existing guidance for medical software on qualification and classification, cybersecurity and clinical evaluation, additional guidance on qualifying as a medical software device was published in March 2021 by MDCG.
However, some problematic issues remain:
- Where nine certified notified bodies existed at the beginning of 2020, as of today 20 notified bodies have received their designation under the MDR. This is of course still a small number compared with 52 under the Medical Devices Directive (MDD).
- For the time being only very few harmonized standards can be used to show conformity with essential requirements under the MDR. IEC/ISO/EN standards suitable under the MDD cannot simply be used to confer a presumption of conformity with the MDR. However, in April 2021 a guidance document on standardization of medical devices was released by MDCG. In the middle of April 2021, a standardization request was adopted by the European Commission and directed to CEN and CENELEC asking them to revise many existing standards and to adopt different new standards within the next three years.
- Unclear issues and delays also affect the fields of clinical evaluation & investigation as well as of post market surveillance & vigilance.
Deadlines for the validity of certificates under the MDR (legacy devices) remain unchanged. Thus, certificates for legacy devices remain valid until 26 May 2024 and legacy devices themselves may be made available or put into service until 27 May 2025 if no significant changes have been made to the product or its intended use. This grace period also applies to up-classified class I devices.