Medical Equipment: EU Law

Department of Health and Social Care written question – answered on 7th October 2019.

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Photo of Chris Green Chris Green Conservative, Bolton West

To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the capacity of Notified Bodies under the terms of the Medical Devices Regulation to meet the demand for their services.

Photo of Nadine Dorries Nadine Dorries The Parliamentary Under-Secretary for Health and Social Care

The Medical Devices Regulation 2017/745 (MDR) will overhaul the current regulatory framework for medical devices.

A key aspect of the MDR is more stringent requirements placed on notified bodies, which conduct third-party conformity assessments on higher risk products. All European notified bodies must undergo a designation process under the MDR to ensure their capacity to comply with the enhanced standards. There is less than a year until the Regulation will be applied in full, and currently five notified bodies are able to assess devices against the MDR, compared to over 50 under the current legislation.

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