# Medical devices: compliance and enforcement of the regulations

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/96166563-83cc-488e-804d-d0368274a17f
Type: Guidance
Published: December 18, 2014
Updated: May 17, 2024

> The Medicines and Healthcare products Regulatory Agency (MHRA) serves as the primary oversight body for medical device safety in the United Kingdom. Operating under the UK's legal framework for medical devices, the agency is responsible for ensuring that all products on the market meet stringent safety and performance standards. This guidance document outlines the procedures for reporting non-compliant devices and describes the MHRA's investigative actions following the receipt of a complaint. While specific inspection dates and individual company violations are not detailed in this general regulatory overview, the agency emphasizes its role in routine market monitoring and its authority to issue enforcement notices when non-compliance is identified. The document provides clarity on the rights of manufacturers when facing such enforcement actions, including their ability to respond or appeal. Stakeholders are instructed to use the provided contact channels to report faulty equipment, while manufacturers are required to maintain continuous compliance with UK regulations. This systematic oversight is designed to protect public health by ensuring that medical technology used within the healthcare system is both safe and effective.

---

## Content

The MHRA is responsible for ensuring that medical devices in the UK comply with legal requirements. This guidance includes: contact details to report a non-compliant medical device information on what we do after receiving a complaint our routine monitoring role the manufacturer’s rights if they have received an enforcement notice

## Attachments

- [How we enforce medical device regulations](/government/publications/report-a-non-compliant-medical-device-enforcement-process/how-mhra-ensures-the-safety-and-quality-of-medical-devices)
- [Report a non-compliant or suspected counterfeit medical device](/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device)