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Medical Equipment: Standards

Asked by Alex EastonIndependentDepartment of Health and Social CareTabled Answered 7 July 2025UIN 64311

The question

To ask the Secretary of State for Health and Social Care, whether his Department plans to adopt the provisions set out in Annex XVI of Regulation (EU) 2017/745 on products without an intended medical purpose.

Answered by Karin Smyth

The Government is working to deliver a future regulatory framework for medical devices that prioritises patient and public safety, gives patients access to the medical devices they need, and ensures the United Kingdom remains an attractive market for innovators.

In 2021, the Government consulted on the future regulation of medical devices, including on proposals to bring certain products without an intended medical purpose but with similar risk profiles to medical devices into the scope of the Medical Devices Regulations 2002. We intend to conduct further consultation and engagement with trusted stakeholders on certain aspects of our proposed policy approach to the future enhancement of our regulations, including on our approach to products without an intended medical purpose.

Moreover, the Government is committed to taking action to address longstanding concerns about the safety of the cosmetics sector and is also exploring options for further regulation of cosmetic procedures, including the practitioners who perform them. We will set out the details of our approach in our response to the consultation on the licensing of non-surgical cosmetic procedures in England, which we will publish as soon as possible.

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