UK MHRA Compliance Support

The MHRA has several key roles and responsibilities, including:

• Protecting public health and patient safety by ensuring the safety, efficacy, and quality of medicines and medical devices in the UK.
• Regulating the UK medical devices market, which involves overseeing the marketing and supply of medical devices in the UK.
• Designating and monitoring UK-approved bodies, which are responsible for assessing whether manufacturers of medical devices meet the necessary Regulatory requirements.
• Conducting market surveillance of medical devices to ensure compliance with regulations and acting when non-compliance is identified.
• Issuing National Patient Safety Alerts (NatPSA) for serious patient safety issues related to medical devices.
• Enforcing legislation on medical devices, which includes a range of investigatory and enforcement powers to ensure the safety and quality of these products.
• Providing guidance and updates on the regulation of medical devices, especially the changes resulting from the UK's exit from the EU.
• Ensuring that manufacturers wishing to place a device on the Great Britain market are appropriately registered with the MHRA.
• Monitoring the safety of healthcare products through reports of adverse drug reactions, defective medicines, counterfeit products, and issues with medical devices.
• Engaging with stakeholders through consultations to develop future legislation for medical devices that aligns with international best practices and is responsive to the needs of patients and the industry.
• Providing Regulatory and scientific advice to organizations and individuals regarding compliance with medicines legislation.
• Implementing provisions under various regulations, such as the Tobacco and Related Products Regulations (TRPR) for e-cigarettes and refill containers.

The MHRA's role in Regulatory affairs includes protecting and promoting public health and patient safety by regulating medicines, medical devices, and blood components. It is responsible for ensuring the safety, quality, and efficacy of these products and oversees their market surveillance in the UK. The MHRA also designates and monitors UK-approved bodies, enforces legislation on medical devices, and has the authority to take action to minimize risks and maximize benefits to patients and the public. Additionally, the MHRA provides scientific and Regulatory advice and is involved in international Regulatory initiatives through partnerships with organizations like the International Coalition of Medicines Regulatory Authorities (ICMRA) and the International Medical Device Regulator’s Forum (IMDRF).

The UK RP acts on behalf of a non-UK manufacturer to carry out specified tasks related to the manufacturer’s obligations under the UK Medical Device Regulations 2002. Their responsibilities include:

• Registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
• Ensuring that the declaration of conformity and technical documentation have been drawn up and, where applicable, an appropriate conformity assessment procedure has been carried out by the manufacturer.
• Keeping a copy of the technical documentation, a copy of the declaration of conformity, and, if applicable, a copy of the relevant certificate available, including any amendments and supplements for inspection by the MHRA.
• Providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device in response to a request from the MHRA.
• Complying with any request from the MHRA to provide samples of the devices or access to the devices or communicating to the manufacturer any request from the MHRA to provide such samples or access if they do not have them.