Guidance

Medical devices: the regulations and how we enforce them

Updated 17 May 2024

MHRA is the designated authority that administers and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure their safety and quality.

Please note that different regulations apply, depending on whether a medical device has been placed on the Great Britain or Northern Ireland market.

The regulation of medical devices in Great Britain

If you are a manufacturer based in the UK and you intend to supply medical devices in Great Britain then you need to be aware of the following legislation:

• the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR)
• the General Product Safety Regulations 2005 (SI 2005 No 1803)
• the Medicines and Medical Devices Act 2021 (MMD Act)

For the purposes of enforcing the UK MDR, the MMD Act introduced a set of enforcement provisions consisting of compliance notices, suspension notices and information notices (along with a specific recall power), which are discussed below.

Schedule 3 of the MMD Act also makes provision for a criminal offence for breaching a provision of the UK MDR. That criminal offence has not yet come into force, and until it is, section 12 of the Consumer Protection Act 1987 will continue to apply to breaches of the UK MDR, so that such breaches will continue to be a criminal offence.

Regulation 61 of the UK MDR places a duty on the Secretary of State (in practice the MHRA) to enforce the UK MDR. These enforcement duties are listed in paragraph 10 of Schedule 5 to the Consumer Rights Act 2015, which enables the MHRA to exercise the investigatory powers (including powers of entry) in Schedule 5 to that Act.

The General Product Safety Regulations 2005 might apply to consumer products that are also medical devices, where these products are not covered by the UK MDR. Therefore, if you are involved in the supply of medical devices that are intended to be used by a consumer, you need to understand your obligations under these regulations. For more information on the General Product Safety Regulations, see Product safety advice for businesses.

The regulation of medical devices in Northern Ireland

If you supply medical devices in Northern Ireland, you need to be aware of the following legislation:

• 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

For the purposes of enforcing the Northern Ireland medical devices legislation, the same MMD Act enforcement provisions discussed above apply. 

Regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021 mirrors the regulation 61 UK MDR duty for the purposes of conferring enforcement duties in relation to Regulation (EU) 2017/745 and EU 2017/746 in Northern Ireland.

In addition, the Market Surveillance (Northern Ireland) Regulations 2021 provide that the enforcers of medical devices legislation are market surveillance authorities for the purposes of the EU’s Market Surveillance Regulation in Northern Ireland and again provides the MHRA with a suite of investigatory and enforcement powers.

MHRA’s enforcement activities

To ensure that medical devices placed on the market and put into service in the UK meet these regulatory requirements we perform the following activities:

• assess all allegations of non-compliance brought to us, using a risk-based system

• monitor the activity of UK approved bodies designated by MHRA to assess the compliance of manufacturers

• investigate medical devices as a result of adverse incident reports or intelligence indicating a potential problem

These activities form part of our market surveillance obligations under Regulation 765/2008 in Great Britain and Regulation 2019/1020 in Northern Ireland. We undertake them in accordance with the statutory principles of the Regulators’ Code.

If we consider that you are breaching the medical devices regulations, typically, the MHRA Devices Compliance Unit will contact you, outlining our concerns and requesting further information.

In the majority of circumstances, we intend to provide high-level guidance on how you can comply with the regulations and what you need to do to ensure that you are not putting members of public at risk unnecessarily.

MHRA’s enforcement powers

If you fail to co-operate with MHRA’s requests and continue to place a non-compliant product on the market, or there is a serious risk to public health, we will consider using our enforcement powers.

The MMD Act provides MHRA with a range of enforcement powers for failing to comply with the medical devices regulations.

MHRA can issue enforcement notices requiring a ‘person’ to take certain action. We can issue these notices not just to manufacturers, but also to others in the marketing and supply chain.

Examples of the notices we can issue under the MMD Act include:

• compliance notices, requiring the person to comply with a specified medical devices provision
• suspension notices, restricting the availability of a device in order to protect health and safety
• safety notices, imposing prohibitions or requirements on the availability of a device in order to protect health and safety
• information notices, requiring a person to provide information to MHRA

If we consider it is necessary to restrict the availability of a medical device to protect health or safety, and the device has already been made available to the public, we can recall the device by taking steps to organise its return. A device may only be recalled if no alternative steps would sufficiently protect health or safety.

Application to vary or revoke an enforcement notice

The MMD Act provides a person affected by one of the above 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.

Offences

If a person breaches an MMD Act enforcement notice or if they breach the UK MDR, they are guilty of an offence, and are liable to imprisonment up to 6 months, or a fine, or both.

Inspections

The majority of our compliance activities are initiated and resolved in writing. However, it may be necessary for us to inspect your site. In some circumstances we may need to take immediate enforcement action if we consider it necessary to protect the public’s health.

Any inspection that an MHRA officer carries out on your premises will follow the procedures in the Consumer Rights Act 2015. This act also provides us with powers to:

• enter premises and inspect the goods (unless the premises are occupied as a person’s residence, in which case an entry warrant can be obtained via a court)

• examine manufacturing procedures and testing arrangements

• require the person to produce documents relating to their business and detain any relevant document

• seize and/or detain suspect records and/or goods which may be required as evidence in proceedings for an offence in respect of a contravention

Appeals procedure

When issuing a decision, MHRA will explain the decision to the manufacturer, including the right to appeal that decision. The appeals route available will depend on which regulatory decision MHRA takes.

As noted above, enforcement notices issued under the MMD Act have appeal procedures set out in section 25 of the MMD Act. An application to appeal a compliance, suspension, safety or information notice should be submitted to the appropriate lower court:

• in England and Wales, a magistrates court
• in Scotland, the sheriff
• in Northern Ireland, a court of summary jurisdiction

MHRA has appointed the Chartered Institute of Arbitrators (CIArb) as the dispute resolution service for certain enforcement and regulatory notices issued by MHRA in respect of devices, as follows:

• clinical investigation notifications (UK MDR, Regulations 16 & 29)
• refusals of clinical investigation applications in Northern Ireland (the Medical Devices (Northern Ireland Protocol) Regulations 2021, regulation 13)
• refusals of performance study applications in Northern Ireland (the Medical Devices (Northern Ireland Protocol) Regulations 2021, regulation 17D)
• notified body or UK approved body designations (UK MDR, regulation 45
• applications for exceptional use of non-complying devices (UK MDR, regulations 12, 26 & 39)

Note that CIArb does not deal with complaints of an administrative nature. These need to be made via the complaints procedure outlined in the section below.

Exceptional use of non-complying devices

A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is no legitimate alternative available. This is called an exceptional use of a non-UKCA or non CE marked medical device. We have a separate guide on exceptional use of devices with more information.

We continue to accept CE-marked medical devices on the Great Britain market for varying dates, depending on the type of device and EU legislation it complies with. For more detail on this see the implementation of the future regulations update on work towards a strengthened future medical devices regime. In addition, qualifying Northern Ireland goods may continue to be placed on the market in GB on the basis of a valid CE marking on an indefinite basis. This arrangement is a result of the government’s commitments to Northern Ireland’s unfettered access to the market in the rest of the UK, and is underpinned by the UK Internal Market Act 2020.

Complaints

Any complaints about the behaviour of MHRA personnel or advice given by them other than on enforcement decisions will be addressed by the complaints procedure.

All MHRA compliance inspectors and investigators are required to conduct their inspections and investigations in accordance with internal operating procedures.