Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether they plan to maintain equivalence with the EU Regulation on Medical Devices 2017/745 during the planned transition period from March 2019 to March 2021.

The Government is committed to the safe and effective regulation of medical devices in the United Kingdom; we continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.

The new EU Devices Regulations entered into force in May 2017. The EU Regulation on Medical Devices 2017/745 will be fully applied from May 2020, during the implementation period agreed with the European Union, and would therefore apply under the terms of the time-limited implementation period.

Under our responsibilities as a Member State, the Medicines and Healthcare products Regulatory Agency continues to work to implement the new Regulations and has met all relevant milestones set out in the legislation.