New MHRA Outline: Enforcement Activities for UK Compliance

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a new outline containing enforcement activities to ensure compliance with medical device regulations in the UK.

The MHRA’s activities include assessing non-compliance allegations, monitoring UK-approved bodies, and investigating adverse incident reports related to medical devices. These actions are part of their market surveillance obligations under Regulation 765/2008 for Great Britain and Regulation 2019/1020 for Northern Ireland.

Consequences of Breaching the MHRA UK MDR Compliance Regarding its Enforcement Activities

When potential breaches are identified, the MHRA’s Devices Compliance Unit typically contacts the involved parties to outline concerns and request further information. If non-compliance persists or poses a serious risk to public health, the MHRA can utilize enforcement powers granted under the Medicines and Medical Devices Act. These powers include issuing compliance, suspension, safety, and information notices to manufacturers and other entities in the supply chain. In cases where a medical device poses significant health risks, the MHRA can also initiate a recall to remove the device from the market.

It is important to note that if a person breaches an MMD Act enforcement notice or if they breach the UK MDR, they are guilty of an offense, and are liable to imprisonment up to 6 months, or a fine, or both.

The MMD Act provides a person affected by one of the above-mentioned enforcement notices with a right of appeal. Under section 25 of the MMD Act, they may apply to the court to have the notice revoked or varied, and their application must be made within 28 days of the notice being served.

In summary, when potential breaches are identified, the MHRA’s Devices Compliance Unit contacts the involved parties to outline concerns and request further information.

For more detailed information, you can visit the UK Government here on Medical devices: the regulations and how we enforce them further guidance.

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If you need help in understanding the new UK MDR compliance update or have questions about how these updates will affect your medical device, contact us so our consultants can assist you.

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• • UK Medical Device Importer Services – MedEnvoy
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