Enforcement policy - Compliance inspection and action - Your rights

MHRA Enforcement Responsibilities
1. 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.

2. MHRA has a duty to enforce this legislation on behalf of the Secretary of State and has 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.

3. The above obligation is met by MHRA in four basic ways:

a. Any complaints about CE marked products, which are drawn to our attention, will be investigated.

b. Selection for inspection of a sample of manufacturers who place their products on the UK market and have registered with the Agency. Inclusion in this proactive exercise does not mean that there has been a breach of the Regulations.

c. Regular monitoring of the activity of Notified Bodies designated by MHRA to assess the compliance of manufacturers of, in the main, higher risk devices.

d. Investigations undertaken as a result of vigilance reports or intelligence indicating that there is a potential problem either with an individual device or range of devices.

4. The investigations at (a), (b) and (d) 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.

5. MHRA adopts the statutory principles of the Hampton Report on Reducing Administrative Burdens: Effective Inspection and Enforcement and the Regulators Compliance Code in carrying out its regulatory functions. The following paragraphs explain MHRA's role and a manufacturer's rights in relation to inspection visits and compliance investigations.

7. MHRA has no legal obligation to give prior notice to undertake an inspection visit. However, manufacturers will normally be informed 14 days before the date of the proposed visit on a date which is mutually convenient to all. 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.

8. An authorised Inspector supported, as necessary by MHRA's product specialist staff will undertake the inspection visit. They 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.

9. Compliance Officers are designated by MHRA's Chief Executive on behalf of the Secretary of State to determine whether a contravention of any safety provision has taken place. Under section 29 of the Consumer Protection Act 1987, Compliance Officers have the right at any reasonable hour to:

a. Enter premises and inspect goods, other than premises occupied only as a person's residence.

b. Examine manufacturing procedures and testing arrangements.

c. Require the production of any records for examination and to take copies of, or copies of any entry in, the records.

d. 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.

10. The visit will normally last for no more than a day, but in practice 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 officer any other assistance or information that he may reasonably require for the purposes of exercising his functions under the Act or to refuse him entry.

11. 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), as implemented by the Medical Devices Regulations 2002. The enabling statute for these provisions is the Enterprise Act 2002 which protects commercially 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.

Enforcement Action
12. In the event that a breach of the Regulations is identified any enforcement action taken by 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 MHRA will only exercise its enforcement powers where it is necessary to protect public health or cooperation is not forthcoming. MHRA has the following range of enforcement powers under the Consumer Protection Act 1987 and Medical Devices Regulations 2002 and the General product Safety Regulations 2005. All of these measures could be exercised before prosecution is considered. Prosecution, which could carry a penalty of up to £5000 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.

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.

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.

General Product Safety Regulations 2005

• Recall Notice. For consumer medical devices only under Regulation 15 of the GPSD Regulations 2005.

Notification of Decisions
13. 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.

14. 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).

15. Where immediate action is necessary, a written statement explaining the reasons for the action will be provided as soon as practicable.

16. The above are all measures introduced to improve enforcement procedures and to make them less burdensome on industry, in accordance with the requirements of the Government Enforcement Concordat.

Appeals
17. At the time an enforcement notice is issued, manufacturers are referred to their right of appeal and how they should go about it.

18. Appeals against conviction are through the Courts but there are a variety of different means of appeal against other enforcement decisions, some of which are prescribed in the Consumer Protection Act 1987 (the Act), the Appeals Procedures and others which are applied administratively by MHRA. The following applies to action taken under the Medical Devices Regulations 2002:

a. Prohibition Notices. The full appeals procedure is set out in the Act (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, MHRA are 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 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 Magistrates' 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.

Complaints
19. Any complaints about the behaviour of MHRA personnel or advice given by them other than on enforcement decisions (see the appeals section) will be addressed by the MHRA complaints procedure. A complaint against a member of MHRA staff may be initiated by writing to his or her senior officer or to the Chief Executive.

Standard Operating Procedures
20. All MHRA Compliance Inspectors are required to conduct their inspections and investigations in accordance with Standard Operating Procedures, 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.

Further Information
21. If you require further information on any of the above, please contact:

Compliance Unit Manager
Medicines and Healthcare products Regulatory Agency
European and Compliance Section
5 Magenta
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ

Tel: 020 3080 7335

MHRA medical devices pro-active and re-active inspections

Inspection
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.

Registered Manufacturers
We have approximately 10,000 registered medical device manufacturers and 435 manufacturers of IVD’s on our data base. We use a risk based approach to select manufacturers from our database for the inspections we carry out which includes product type, any reported incidents, risk to public health and fair geographic application.

Risk based projects:
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.

MHRA medical devices re-active investigations
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 and also in line with the Government Enforcement Concordat 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 MHRA Enforcement Responsibilities above, or can be obtained in hard copy by contacting our Compliance Unit Manager:

Bruce Petrie
Compliance Unit Manager
Medicines and Healthcare products Regulatory Agency
European and Compliance Section
5 Magenta
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ

Tel: 020 3080 7335