The new article provides an overview of the regulatory approach to medical devices allowed for marketing and use in the United Kingdom.
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The Medicines & Healthcare Products Regulatory Agency (MHRA) has published a revised information sheet dedicated to the existing legal framework. The document outlines the key points related to the regulatory requirements for medical devices and also provides additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, the authority reserves the right to make changes to the recommendations and clarifications provided, should this be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The Regulation of Medical Devices in Great Britain
In accordance with the existing legal framework, MHRA is responsible for administering and enforcing the laws governing medical devices in the UK. This includes ensuring their safety and quality through a range of investigatory and enforcement powers. In Great Britain, specific legislation applies to manufacturers who intend to supply medical devices, including:
- The Medical Devices Regulations 2002 (UK MDR),
- The General Product Safety Regulations 2005, and
- The Medicines and Medical Devices Act 2021 (MMD Act).
The MMD Act introduces enforcement provisions such as compliance notices, suspension notices, and information notices, along with a specific recall power. It also outlines criminal offenses for breaching the UK MDR, though these provisions are not yet in force. Until then, section 12 of the Consumer Protection Act 1987 applies, making such breaches criminal offenses.
Regulation 61 of the UK MDR places the duty of enforcement on the Secretary of State, executed by the MHRA, enabling it to use investigatory powers listed in Schedule 5 of the Consumer Rights Act 2015, including powers of entry. The General Product Safety Regulations 2005 may also apply to consumer products that are medical devices if they are not covered by the UK MDR.
The Regulation of Medical Devices in Northern Ireland
In Northern Ireland, different regulations apply due to its unique status post-Brexit. Key legislation includes:
- The EU Medical Devices Regulation (2017/745)
- The EU in vitro Diagnostic Medical Devices Regulation (2017/746)
- The Medical Devices (Northern Ireland Protocol) Regulations 2021
- The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
- The MMD Act
- The Market Surveillance (Northern Ireland) Regulations 2021
These regulations are enforced using the same MMD Act provisions. Regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021 mirrors Regulation 61 of the UK MDR for enforcement purposes. The Market Surveillance (Northern Ireland) Regulations 2021 designate enforcers as market surveillance authorities under the EU’s Market Surveillance Regulation, providing MHRA with investigatory and enforcement powers.
MHRA’s Enforcement Activities
According to the guidance, the MHRA ensures that medical devices on the UK market meet regulatory requirements through various activities, including:
- Assessing allegations of non-compliance using a risk-based system
- Monitoring the activity of UK-approved bodies designated by MHRA
- Investigating medical devices following adverse incident reports or intelligence
These activities form part of market surveillance obligations under Regulation 765/2008 in Great Britain and Regulation 2019/1020 in Northern Ireland, adhering to the Regulators’ Code. If non-compliance is suspected, the MHRA Devices Compliance Unit typically contacts the manufacturer for more information, offering high-level guidance on achieving compliance and minimizing public risk.
MHRA’s Enforcement Powers
In cases of continued non-compliance or serious public health risks, MHRA may exercise its enforcement powers under the MMD Act. These include issuing various notices:
- Compliance Notices: Require adherence to specific medical device provisions;
- Suspension Notices: Restrict the availability of a device to protect health and safety;
- Safety Notices: Impose prohibitions or requirements on a device’s availability;
- Information Notices: Demand information from relevant parties.
In situations where restricting a device’s availability is necessary to protect health and safety, MHRA can organize the recall of the device if no other measures suffice.
Application to Vary or Revoke an Enforcement Notice: Offenses
As set forth by the relevant legislation, those affected by an enforcement notice under the MMD Act have the right to appeal. Section 25 of the MMD Act allows applications to the court to have a notice revoked or varied within 28 days of service.
Breaching an MMD Act enforcement notice or the UK MDR is a criminal offense, punishable by up to six months in prison, a fine, or both.
Inspections
The authority further explains that even though most compliance activities are resolved in writing, MHRA may still inspect sites if necessary to protect public health. Inspections follow procedures in the Consumer Rights Act 2015, which grants the authority special powers to:
- Enter premises and inspect goods
- Examine manufacturing and testing procedures
- Demand business-related documents and detain any relevant ones and
- Seize or detain suspect records or goods as evidence
Appeals Procedure
When issuing decisions, MHRA explains the decision and the right to appeal. The appeal route depends on the regulatory decision taken. Appeals against enforcement notices under the MMD Act are made to:
- Magistrates Court in England and Wales
- Sheriff in Scotland or
- Court of summary jurisdiction in Northern Ireland.
The Chartered Institute of Arbitrators (CIArb) handles dispute resolution for certain enforcement and regulatory notices. Complaints of an administrative nature are addressed through a separate complaints procedure.
Exceptional Use of Non-Complying Devices
According to the guidance, manufacturers can apply to supply a non-compliant medical device if necessary to protect a patient’s health with no legitimate alternatives. CE-marked devices are still accepted in the Great Britain market, depending on the device type and EU legislation. Northern Ireland goods with valid CE markings can be placed on the GB market indefinitely, supported by the UK Internal Market Act 2020.
Complaints
Complaints about MHRA personnel or advice, excluding enforcement decisions, are handled through the MHRA complaints procedure. All inspectors and investigators adhere to internal operating procedures during inspections and investigations.
Conclusion
In summary, the present guidance document is issued by the MHRA to guide medical device manufacturers and other parties involved through the key points of the existing legal framework. The document provides clarifications regarding the most crucial matters and explains the way certain regulatory provisions apply.
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