The secretary of state for health, via the MHRA, is responsible for administering legislation relating to medical devices and for ensuring the safety and quality of devices. The relevant legislation is the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) and the General Product Safety Regulations 2005 (SI 2005 No 1803). For the purposes of enforcement, these Regulations are safety regulations under the Consumer Protection Act 1987.
In this section...
Reporting a non-compliant medical device
If you have any concerns about a medical device being placed on the market without complying with the Medical Devices Regulations please let the Devices Compliance and Enforcement Unit know through the following mailbox: firstname.lastname@example.org
The sort of information we would require to pursue allegations of non-compliance would be as follows:
- the manufacturer’s name and address
- details of the product involved
- the breach of the regulations alleged
- any evidence you might have to provide grounds for investigation.
Once this information has been received it will be risk assessed to determine whether an investigation is warranted.
Allegations of non-compliance will be treated confidentially in accordance with the provisions in the medical devices directives. The confidentiality provisions in the medical devices directives mean that we cannot let complainants have details of any investigation with a third party. These provisions are also an advantage to complainants since their details will not be released to the third party against which the allegations are made, unless required under the criminal procedure rules in court cases.
The Case Referral Centre - Devices (CRC email: email@example.com) provides the single point of contact for all medical device enquiries and referrals relating to possible non-compliant or criminal activity involving medical devices. The CRC Team is committed to dealing with all such referrals in a timely manner according to risk priority.
However, appropriate action will be taken to resolve any breaches identified. This may range from prosecution where there is a serious risk to public health, refusal to bring the device into compliance, compliance cannot be achieved within a reasonable time frame or repeated non-compliance, to other forms of less noticeable compliance action while the product remains on the market in less serious cases.
Details of the MHRA's powers and your rights are given below.
Enforcement policy – your rights
The Agency’s Medical Devices Compliance and Enforcement Unit will investigate all potential breaches and alleged criminal activity in line with the Police and Criminal Evidence Act (PACE) and in accordance with the Hampton principles of proportionality. The Agency has produced a booklet which details our powers under the relevant pieces of legislation and manufacturer’s rights in dealing with any investigations carried out by the Agency. We also have an Agency Enforcement Strategy (117Kb) which sets out the MHRA's strategy for the enforcement of medicines and medical devices legislation.
The secretary of state for health is responsible for administering legislation relating to medical devices and for ensuring the safety and quality of devices. The relevant legislation is the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) and the General Product Safety Regulations 2005 (SI 2005 No 1803). For the purposes of enforcement, these Regulations are safety regulations under the Consumer Protection Act 1987.
The MHRA has a duty to enforce this legislation on behalf of the secretary of state for health and has the delegated responsibility for England, Wales, Scotland and Northern Ireland. This involves establishing that the Medical Devices Regulations and the General Product Safety Regulations (as they relate to ‘consumer medical devices’) have been complied with and ensuring that the appropriate action is taken wherever necessary to prohibit or restrict unsafe products being placed on the market and/or put into service.
The MHRA meets this obligation in four basic ways:
- we will consider any complaints about CE-marked products that are drawn to our attention
- by looking at areas that are presenting a problem in terms of non-compliance and proactively target the devices identified
- regular monitoring of the activity of notified bodies designated by the MHRA to assess the compliance of manufacturers of, in the main, higher risk devices
- we will undertake proactive investigations as a result of vigilance reports or intelligence indicating that there is a potential problem either with an individual device or range of devices or cases selected from reactive cases that meet a pre-determined criteria.
The Agency carries out a risk-based analysis to prioritise and carry out investigations.
The investigations detailed in 1, 2 and 4 above will normally be initiated and resolved in writing by requesting technical and other information for documentary review. Inspection visits will generally only be undertaken where the documentation available indicates it is merited to confirm compliance, or where technical documentation can only be properly reviewed on site, as for custom-made devices. Where a breach of the Regulations is identified, manufacturers will normally be given the opportunity to come into compliance voluntarily. Immediate enforcement action will only be taken where necessary to protect public health.
The MHRA adopts the statutory principles of the Regulators' Code in carrying out its regulatory functions.
The following paragraphs explain the MHRA's role and a manufacturer's rights in relation to inspection visits and compliance investigations.
The MHRA has no legal obligation to give prior notice to undertake an inspection visit. However, we will consider a pre-notified visit as part of the normal risk assessment and if this is required, we will normally give 14 days’ notice. One of the aims of the visit is to confirm that the essential requirements are being complied with in practice. There will therefore be no need to disrupt the manufacturing process and it will not be essential for senior management to be present or for any special preparations to be made. The date of the visit will only be changed in exceptional circumstances.
An authorised inspector supported, as necessary, by the MHRA's product specialist staff will undertake the inspection visit. Inspectors have been fully trained to carry out inspection duties and they carry an authorisation card, which will be produced on request. Inspectors make their own travel, accommodation and catering arrangements and they will not accept any offers that could possibly be construed as affecting or influencing their judgement.
Compliance inspectors and investigators are designated by the MHRA's chief executive on behalf of the secretary of state for health to determine whether a contravention of any safety provision has taken place. Under section 29 of the Consumer Protection Act 1987, compliance inspectors and investigators have the right to the following at any reasonable hour:
- Enter premises and inspect goods, other than premises occupied only as a person's residence.
- Examine manufacturing procedures and testing arrangements.
- Require the production of any records for examination and to take copies of, or copies of any entry in, the records.
- 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.
The visit will normally last for no more than a day, but in practice will last a lot less and as outlined above, access may be required to any records, technical specifications or parts of the manufacturing site to confirm compliance with the essential requirements specified in the Regulations.
It is an offence under section 32 of the Consumer Protection Act 1987, without reasonable cause, to fail to give such an inspector any other assistance or information that he may reasonably require for the purposes of exercising their functions under the Act or to refuse them entry.
Any information provided will be treated in accordance with 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) and Article 15 of the Active Implantable Medical Devices Directive (90/385/EEC), which protects sensitive information and lays down gateways for requests to release information to third parties only in specific circumstances such as for the investigation of a crime.
In the event that a breach of the Regulations is identified, any enforcement action taken by the MHRA will be proportionate to the problem and handled in line with legal requirements such as the Police and Criminal Evidence Act and the principles of better regulation laid down in the Hampton Report. Manufacturers will normally be given the chance to put matters right themselves on a voluntary basis first and the MHRA will only exercise its enforcement powers where it is necessary to protect public health or cooperation is not forthcoming.
The MHRA has a range of enforcement powers under the Consumer Protection Act 1987, the Medical Devices Regulations 2002, and the General Product Safety Regulations 2005, listed below. All of these measures could be exercised before prosecution is considered. Prosecution, which could carry a penalty of up to £5,000 per offence and/or six months imprisonment, would normally only be undertaken as a last resort where either a serious offence has been committed or all else has failed.
Powers under the Consumer Protection Act 1987
- Offences against the Safety Regulations (Section 12). These restrictions relate to the supplying, offering or agreeing to supply goods where the safety regulations prohibit a person from doing so.
- Prohibition Notices (Section 13). These prohibit the supply of any goods which are considered to be unsafe or are not in compliance with Regulations.
- Notices to Warn (Section 13). These require a manufacturer to issue at his own expense a warning about any relevant goods, which are considered unsafe.
- Suspension Notices (Section 14). These suspend the supply of any goods for a period of up to six months, where it is suspected that a safety provision has been contravened. Compensation may be payable if it is later established that there was no contravention.
- Forfeiture Orders (Section 16 and 17). Enforcement authorities may apply for an order for the forfeiture of goods where there has been a contravention of a safety provision.
- Obtaining Information (Section 18). MHRA, on behalf of the Secretary of State, has the power to serve a notice requiring a person to furnish information or to produce records for the purposes of deciding whether to serve, vary or revoke a prohibition notice or a notice to warn.
- Test Purchases (Section 28). This gives enforcement authorities the power to make test purchases for the purposes of ascertaining whether or not the Regulations have been breached.
Powers under the Medical Devices Regulations 2002
- Compliance Notice (Regulation 62(1)). In addition, Regulation 62(1) of the Medical Devices Regulations 2002 provides the power to issue notices for non-compliance with the Regulations (Compliance Notice). These powers are in the main, for technical breaches where a device is thought not to conform to an essential requirement, but where it does not compromise health or safety. The notice generally requires the person on whom it is served to ensure that the device conforms within the period stated in the notice.
- Restriction Notice. Regulation 63(1) of the Medical Devices Regulations 2002 provides that where MHRA is of the opinion that it is necessary to restrict the availability of a particular medical device, or of devices of a particular class or description, in order to protect the health or safety of any individual or individuals of any class or description, they may serve on any person a Restriction Notice. This will include such directions restricting the availability of that device or those devices as appears to be necessary.
Powers under the General Product Safety Regulations 2005
Recall Notice. For consumer medical devices only under Regulation 15 of the GPSD Regulations 2005.
Notification of decisions
Where you are notified of a need to take remedial action, the Notice will include a statement of the reasons why the MHRA considers the remedial action to be necessary.
Unless immediate action is merited on safety grounds, you will be notified of any intention to take formal enforcement action. You have the right, within a specified period of not less than 14 days, to make formal written representations to MHRA before any action is taken, as stated in Regulation 64(1) of the Medical Devices Regulations 2002 (as amended).
Where immediate action is necessary, a written statement explaining the reasons for the action will be provided as soon as practicable.
a. Prohibition Notices
The full appeals procedure is set out in Schedule 2, Part I of the Consumer Protection Act 1987. A manufacturer may make written representations to the MHRA chief executive (acting on behalf of the secretary of state). The chief executive will decide whether to revoke the notice outright or to appoint an independent adjudicator to consider the manufacturer's views and report back. The final decision will be taken by the chief executive, in appropriate cases with ministerial approval, but the chief executive has a duty to consider the adjudicator's report. The final decision could uphold the notice, revoke it completely or make variations to it. In the case of the latter, the variation may not be more onerous than the original notice.
b. Notice to Warn
Before a notice of this type is issued, the MHRA is required to provide the manufacturer with a draft of the notice and a written statement as to why it is necessary (Schedule 2 Part II of the Consumer Protection Act 1987). At that stage the manufacturer may take written representations to the MHRA chief executive, who will consider the appeal in accordance with the appeals procedure set out in the Act.
c. Suspension Notices
An application to set aside a Suspension Notice can be made to a magistrates' court in England, Wales and Northern Ireland or by summary application to a sheriffs' court in Scotland (s.15 of the Consumer Protection Act 1987).
d. Forfeiture Orders
These are issued by a magistrate's court on application by the MHRA or through the procurator fiscal to the sheriff in Scotland (ss.16 & 17 of the Consumer Protection Act 1987). The court can only issue the order if it is satisfied that there has been a contravention of any safety provision in respect of the goods concerned. If the manufacturer is aggrieved by the making of such an order, he can appeal through the Crown Court in England and Wales, the County Court in Northern Ireland and to the High Court by Bill of Suspension in Scotland.
e. Notice to Produce Documents
Requests for information will be covered by administrative appeal procedures, which will be similar to the independent adjudicator system for Prohibition Notices. The first step is for a manufacturer to make a written representation to the MHRA chief executive.
f. Entry to Premises for Inspection
Decisions to inspect goods, enter premises, examine procedures, require the production of goods, seizure and detention of goods or records and requirement to open containers or vending machines will always be dependent upon the circumstances surrounding the investigation of a manufacturer's alleged non-compliance with the Regulations. However, if the occupier of the premises does not voluntarily permit entry or where it is anticipated that permission will not be granted to enter the premises or for other powers of search necessary, the enforcement authority must apply to a magistrates' court for a warrant. Section 30(2) of the Consumer Protection Act 1987 sets out the criteria for the issue of such a warrant. Appeals against (or where no proceedings have been brought, a complaint about) the retention of goods following seizure can be made to a magistrates' court in England, Wales and Northern Ireland or by summary application to the sheriff in Scotland.
g. Restriction Notices
The procedure for appealing against Restriction Notices is the same as that for appealing against a Suspension Notice (an appeal through the magistrate's court). However, except in cases of emergency, companies will be given the right to make prior representations to the MHRA chief executive before a Restriction notice is issued.
h. Recall Notices
Under Regulation 17 of the General Product Safety Regulations 2005 an application can be made to the courts for the Notice to be set aside within 7 days of it being served.
Any complaints about the behaviour of MHRA personnel or advice given by them other than on enforcement decisions will be addressed by the MHRA complaints procedure.
Standard operating procedures
All MHRA compliance inspectors and investigators are required to conduct their inspections and investigations in accordance with standard operating procedures (SOPs), which includes having to undertake a risk assessment prior to each site visit. In the event of a complaint, a copy of the relevant procedure will be made available on receipt of a written request from the manufacturer. The Agency will not release the SOPs that relate to covert and directed surveillance and prosecutions.
Pro-active and reactive inspections
Part of our duties is to act on behalf of the secretary of state to ensure that all medical devices placed on the UK market are compliant with the Medical Device Regulations 2002 (as amended). We do this in a number of ways.
We will undertake proactive investigations as a result of vigilance reports or intelligence indicating that there is a potential problem either with an individual device or range of devices or cases selected from reactive cases that meet a pre-determined criteria.
We also undertake risk-based projects as a result of intelligence and vigilance of post-market surveillance. This may include our inspectors working with other member states within the European Community and can include any classification of medical device where there is a concern in terms of public health or safety.
The Agency aims to investigate all allegation of non-compliance reported to us regarding medical devices, which may affect public health. We are committed, as the Hampton Report recommends, to resolving non-compliance issues with manufacturers rather than taking enforcement action. However, if we are unable to resolve non-compliance by working with the manufacturer in an acceptable time period then enforcement action will be taken as outlined in the section ‘Enforcement responsibilities’ above.
Market surveillance and accreditation regulations
The European Commission Regulation (EC) no 765/2008 on accreditation and market surveillance (known as RAMS) came into force in January 2010. It forms part of the Commission's movement of goods package. The main objective is to enhance EU competitiveness by strengthening the systems that support harmonisation legislation both before products (including medical devices) are placed on the market and afterwards, in order to create a level playing field.
We have prepared a document (104Kb) that gives a detailed explanation of the regulations and how the MHRA intends to fulfil the obligations which are placed on it.
Product Safety and Market Surveillance package
The EC has recently published its proposals on a new 'Product Safety and Market Surveillance package', available from the European Commission's website.
The proposals will be discussed in the European Parliament and in the Council and are expected to come into effect from 2015.
What does the Product Safety and Market Surveillance package consist of?
The main elements of the package are:
- a proposal for a new regulation on consumer product safety and
- a proposal for a single regulation on market surveillance of products.
Moreover, in a multi-annual plan for market surveillance the Commission sets out 20 concrete actions for how it will improve implementation of the current market surveillance rules from now until 2015. The Commission also adopted a report on the implementation of Regulation (EC) No 765/2008 on accreditation and market surveillance and a Communication on more product safety and better market surveillance in the Single Market for products that ties the whole package together.
Why are new rules needed and when should the proposed new rules start to apply?
The proposed new Consumer Product Safety Regulation aims at clarifying the regulatory framework for consumer products to make it fit for purpose to meet the challenges of a globalised market. It takes account of the regulatory developments in the EU during the last decade. The basic principle that all consumer products must be safe when made available on the market is kept. More emphasis is put on enhanced product identification and traceability. Also the procedures to develop new or update existing standards are significantly simplified, enhancing the role of standards in the field of consumer product safety.
The proposed new Market Surveillance Regulation aims at simplifying the Union framework for market surveillance of non-food products so that it works more effectively in order to protect public interests such as human health and safety or the environment. Enforcement rules that apply to products will be more uniform, market surveillance procedures streamlined and the activities of market surveillance authorities in the EU will benefit from enhanced coordination and monitoring.
Exceptional use of non-complying devices
Approval can be sought from the Agency to supply and put into service non-complying devices on humanitarian grounds.
We have guidance for clinicians and manufacturers to help clarify how, and under what circumstances they may make applications to the competent authority (the MHRA) for the use of a non CE-marked device for an individual, named patient in the interest of the protection of their health.
Regulation 12(5) of the Medical Devices Regulations 2002 allows the secretary of state to authorise the use of a medical device which has not undergone or completed the CE marking procedures if he is satisfied that it would be in the interests of the protection of health. The same provision is made for active implantable medical devices in Regulation 26(3) and for in vitro diagnostic medical devices in Regulation 39(2). The Regulations also allow the secretary of state for health to authorise the use of a custom-made medical device, which has not complied with the standard conformity assessment procedure on the above ground. The secretary of state for health has delegated the responsibility for considering applications for the special use of non-complying medical devices to the MHRA.
The special procedure for such cases to be considered is detailed below, together with the criteria under which such applications may be made.
In the guidance below ‘medical device’ means a device falling within the scope of the Regulations.
Criteria for exceptional use of non-complying medical devices
Use of an individual non-complying medical device, for a single, named patient, is allowable only in the exceptional circumstances such as:
no alternative CE marked devices are available for this treatment
where it has been demonstrated that the morbidity and/or mortality are significantly reduced with the use of the device in question compared to those using alternative available treatment.
Legal responsibility for making a formal request for authorisation lies with the manufacturer. However, both the manufacturer and the clinician in charge of the patient concerned must complete the relevant forms and submit them to the MHRA. An application must be made for each patient for which authorisation for exceptional use is sought.
The information required is detailed in the forms below:
In vitro medical device (345Kb)
Action by the MHRA
Once the MHRA receives the completed forms, the request will be considered as a matter of priority. If any of the information provided is unclear or further details are needed, the MHRA will contact the manufacturer or clinician for clarification. The decision on the application will take account of the implications of the use of the device in question for the particular purpose and individual patient, and the health and public safety provisions of the Regulations.
The MHRA’s decision (usually made within a maximum of 48 hours) will be sent to the manufacturer by email where possible. If the use of the device as requested is authorised, the decision will also include details of any obligations the manufacturer must fulfil. Similarly, a decision will be sent to the clinician.
It will be necessary to submit repeat applications if another patient requires the use of the same device. A separate assessment will be made of the public health need on each occasion. However, in very rare cases, where a device is likely to be the subject of multiple applications and be needed at extremely short notice, consideration may be given to granting authorisation for an emergency stock to be held.
The MHRA has a formal appeals procedure, with an independent assessor, in the event that an individual or a company is dissatisfied with a decision taken by the Agency as part of its obligations under the relevant medical devices legislation.
Note that this does not deal with complaints of an administrative nature. The handling of such complaints is described on a separate page of our website.
The various appeals and set procedures are detailed in three different UK legislative texts.
Who may appeal?
Any manufacturer, authorised representative, supplier, distributor or notified body that is subject to the Regulations.
Against what type of decision can you appeal?
Listed below are the relevant parts of the UK legislation where appeals process can be found.
Some notifications or decisions that the MHRA make will not be processed through our procedures below but will entail the manufacturer going straight to court. The MHRA will explain each regulatory decision to the manufacturer at the time of issuing the decision, including their right to appeal.
Relevant part of the legislation
|Clinical investigation notifications||Regulations 16 and 291|
|Notified body designation||Regulation 451|
|Applications for exceptional use of non-complying devices||Regulations12(5), 26(3) and 39(2)1|
|Restriction Notice||Regulation 63(1)1|
|Suspension Notice||Section 14(1)2|
|Prohibition Notice||Section 13(1) (a)2|
|Notice to Warn||Section 13(1) (b)2|
|Recall Notice||Regulation 15(1)3|
1 The Medical Devices Regulations 2002
2 Consumer Protection Act 1987
3 General Product Safety Regulations 2005
In line with the requirements of the Hampton Report on Reducing Administrative Burdens - Effective Inspections and Enforcement, the MHRA keeps its guidance documents under constant review. If you have any feedback, particularly on the presentation, accessibility or clarity of any of our guidance please inform us via email: firstname.lastname@example.org