© Crown copyright 2017
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: firstname.lastname@example.org.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/how-mhra-ensures-the-safety-and-quality-of-medical-devices
Medical devices: the regulations and how we enforce them
MHRA is the designated competent 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.
The Regulation of Medical Devices in the UK
If you are a manufacturer based in the UK and you intend to supply medical devices in the UK or Europe then you need to be aware of the following regulations:
- the Medical Devices Regulations 2002 (SI 2002 No 618, as amended)
- the General Product Safety Regulations 2005 (SI 2005 No 1803)
These regulations are safety regulations under the Consumer Protection Act 1987 and as such, the MHRA can investigate any business activity that is covered by these regulations in accordance with the Consumer Rights Act 2015.
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 notified 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
carry out proactive risk-based projects with other member states in Europe to identify emerging risks
These activities form part of our market surveillance obligations under EU regulation 765/2008 and we undertake them in accordance with the statutory principles of the Regulators’ Code. More information on the MHRA’s role in market surveillance is available here.
If you are considered to be breaching the regulations, typically, you will be contacted by the MHRA compliance unit 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 the requests and continue to place a non-compliant product on the market or there is a serious risk to public health then we will consider using our enforcement powers.
The Consumer Protection Act 1987
Examples of the powers we have under the Consumer Protection Act 1987 include the following:
prohibition notices to ban the supply of any goods which are considered unsafe or do not comply with regulations;
notices to warn which requires a manufacturer to issue a warning at his own expense about any relevant goods, which are considered unsafe;
suspension notices to suspend the supply of any goods for up to six months, where it is suspected that a safety provision has been contravened;
forfeiture orders for goods where there has been a contravention of a safety provision;
notice to obtain information where MHRA requires a person to furnish information or to produce records to help decide whether to serve, vary or revoke a prohibition notice or a notice to warn.
The Medical Devices Regulations 2002 gives us the power to issue some of these notices for failing to comply with the regulations themselves. This can be for technical breaches that do not compromise health or safety.
The Medical Devices Regulations 2002
Under the Medical Devices Regulations 2002 we can issue a:
compliance notice to formally outline perceived offences and request you to correct a non-compliance
restriction notice, in order to restrict the availability of a particular medical device, or of devices of a particular class or description.
The General Product Safety Regulations 2005
As well as the Medical Device Regulations 2002, the General Product Safety Regulations 2005 outline requirements for all consumer products and therefore applies to consumer products that are also medical devices.
Therefore, if you are involved in the supply of medical devices that are intended to be used by a consumer, you will need to understand your obligations under these regulations.
If MHRA considers that you have supplied a dangerous medical device to consumers then we can issue a notice requiring you to organise the return of the product under these Regulations.
Information on the General Product Safety Regulations is available here.
Failure to comply with the regulations
If MHRA considers that you have committed a serious offence by failing to comply with these regulations or the conditions of a notice issued to you then you may be subject to prosecution. Prosecution could carry a penalty of an unlimited fine and/or 6 months’ imprisonment.
The majority of our compliance activities are initiated and resolved in writing. However, it may be necessary for us to inspect your site. Furthermore, in certain circumstances we may be required to take immediate enforcement action if it is seen as 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)
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.
Any information provided to us in the course of an inspection will be treated as confidential according to:
the confidentiality provisions in Article 20 of the Medical Devices Directive (93/42/EEC)
Article 19 of the In Vitro Diagnostic Medical Devices Directive (98/79/EEC)
Article 15 of the Active Implantable Medical Devices Directive (90/385/EEC).
These were implemented into UK legislation by the Enterprise Act 2002, which is a gateway allowing requests to release information to third parties only in specific circumstances.
If you disagree with a decision being made by the MHRA then you have the right to appeal that decision. The appeals route you need to take will depend on which regulatory decision MHRA takes.
You can appeal MHRA’s decision to issue the notices/notifications through the Chartered Institute of Arbitrators (CIArb):
- prohibition notice (Consumer Protection Act, schedule 2, part 1)
- notice to warn (Consumer Protection Act, schedule 2, part 2)
- recall notice (General Product Safety Regulations, Regulations 15 & 17)
- clinical investigation notifications (Medical devices Regulations, Regulations 16 & 29)
- notified body designations (Medical Devices Regulations, Regulation 45
- applications for exceptional use of non-complying devices (medical devices regulations, regulations 12, 26 & 39)
Appeals against other medical device regulatory decisions taken by MHRA will be specified in the relevant legislation and will not be processed through CIArb. In such cases you should follow the prescribed process, which will usually mean you need to appeal directly to the courts.
MHRA will explain each regulatory decision to the manufacturer when they issue the decision, including their right to appeal.
Please 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-CE marked medical device. We have a separate guide on exceptional use of devices with more information.
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.