Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what the timetable is for the UK's complete implementation of the EU Medical Devices Regulation which takes full effect in 2020.

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 European Union Devices Regulations entered into force in May 2017. The EU Medical Devices Regulation will be fully applied from May 2020, during the implementation period agreed with the EU. This would not automatically follow for the new EU Regulations for in vitro diagnostic (IVD) medical devices, which does not apply until May 2022.

However, elements of both new Devices Regulations have been applied directly in UK law since May 2017, meaning devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements.

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.