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Medical Equipment: Certification

Department of Health and Social Care written question – answered on 25th March 2020.

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Photo of Chris Green Chris Green Conservative, Bolton West

To ask the Secretary of State for Health and Social Care, how many staff members within the Medicines and Healthcare products Regulatory Agency are reviewing re-certification applications to comply with the Medical Devices Regulation.

Photo of Chris Green Chris Green Conservative, Bolton West

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that all medical device businesses are re-certified so that they comply with the Medical Device Regulation before the May 2020 deadline.

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

The new Medical Device Regulation (MDR), which will become United Kingdom law from 26 May 2020 as part of the European Union Withdrawal Act 2019, substantially strengthens the regulatory framework for medical devices and notified bodies and manufacturers are having to make significant changes to meet the enhanced requirements.

The Government recognises the importance of having competent notified bodies in place to ensure continuity of supply of products to the UK market. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with UK industry and notified bodies on an ongoing basis to ensure that they are prepared for the implementation of the MDR.

There are also transitional provisions in place which enable existing CE marked devices to remain valid for sale until the date of expiry of that certificate. This means in practice that all devices on the UK market do not require immediate re-certification.

The MHRA will publish further guidance on how we intend to support businesses who may struggle to obtain certification under the MDR and to ensure continuity of supply of medical devices to UK patients.

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