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Delay to the implementation of the Medical Device Regulations 2017/745 (MDR)
29 April 2020
The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021, in light of the Covid-19 pandemic.
This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU. The MHRA are taking steps to plan for after the end of the transition period, and they will issue guidance in due course. Patient safety and ensuring patient access to medical devices will be prioritised when decisions on regulations are taken.
In the meantime, the existing regulatory requirements should continue to be met.