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Written question asked by Baroness Walmsley (Liberal Democrat) on Wednesday, 4 July 2018, in the House of Lords. It was due for an answer on Wednesday, 18 July 2018. It was answered by Lord O'Shaughnessy (Conservative) on Wednesday, 18 July 2018 on behalf of the Department of Health and Social Care.

Medical Equipment: EU Law

Question

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.

Answer

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.

Secondary information

Type
Written question
Reference
HL9247
Session
2017-19
Subjects
EU law Medical equipment Transitional arrangements Brexit
Link
View this Written question on www.parliament.uk