Medical Equipment: EU Law:Written question - 292265

Asked by Chris Green
(Bolton West)
Asked on: 30 September 2019
Department of Health and Social Care
Medical Equipment: EU Law
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.
Answered by: Ms Nadine Dorries
Answered on: 07 October 2019

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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