Medical device appeals

Contents

1. Background: MHRA's regulatory responsibilities

• Relevant legislation
• How the MHRA operates in practic
• Enforcement procedures

2. Appeals procedures

• Who may appeal
• Against what types of decision does there lie an appeal?
• Value of independent assessor

3. How to appeal?

• Clinical investigation notifications
• Notified Body designation
• Notifications for the use of non-complying devices
• Prohibition notices, notices to warn and suspension notices
• Restriction notices

4. Further information

1. Background: MHRA's regulatory responsibilities

Relevant legislation

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible as the United Kingdom's Competent Authority (CA), on behalf of the Secretary of State for Health, for administering and ensuring compliance with the following medical device legislation in England, Wales, Scotland and Northern Ireland:

• The Medical Devices Regulations 2002 (SI 2002 No 618) which transpose the European Union Council Directives 90/385/EEC regarding active implantable medical devices; 93/42/EEC regarding medical devices; 98/79/EC regarding in vitro diagnostic medical devices and 2000/70/EC and 2001/104/EC regarding medical devices incorporating stable derivatives of human blood or plasma.
• The Medical Devices (Amendment) Regulations 2003 (SI 2003 No 1697) which transpose European Union Commission Directives 2003/12/EC on the reclassification of breast implants and 2003/32/EC on medical devices manufactured utilising tissues of animal origin.
• The General Product Safety Regulations 2005 (SI 2005 No 1803) transpose European Union Council Directive 2001/95/EC on general product safety. The Directive revises the earlier European Union Council Directive 92/59/EEC which was transposed into UK law under the General Product Safety Regulations 1994 (SI 1994 No 2328).
• All of the above regulations (the Regulations) are safety regulations made under the Consumer Protection Act 1987 (CPA) and the European Communities Act 1972.

How the MHRA operates in practice

MHRA meet its Competent Authority (CA) functions by:

i. enforcing the Regulations by:

• investigating allegations received about possible non-compliance with the Regulations; and
• operating a pro-active inspection programme where manufacturers are randomly selected for inspection by MHRA's own staff;

ii. designating and auditing the activities of UK Notified Bodies;

iii. investigating post-market surveillance reports received from medical device manufacturers and users;

iv. considering notifications of clinical investigations;

v. maintaining a register of certain types of manufacturers.

Enforcement Procedures

Where a breach of the Regulations is detected, it can often be quickly rectified and MHRA will usually try to agree corrective action with the manufacturer. However, in a few cases, for example where public health and safety are at risk or where a manufacturer refuses to take corrective action, MHRA will consider taking formal enforcement action, such as issuing notices prohibiting, restricting the supply and/or recall of the devices in question.

Where any form of regulatory action or decision is taken under the Medical Devices Regulations 2002, the manufacturer will be given an explanation of the decision and details about its right of appeal. In addition, where a decision has been taken which means the product cannot be marketed, or marketing has been restricted, MHRA will give the manufacturer or authorized representative prior notice that representations can be made before a final decision is made. This will not apply where emergency action is needed to protect public health and safety. Under the General Product Safety Regulations 2005, MHRA will whenever feasible, allow a supplier and/or distributor of medical devices which are consumer products, notice that representations can be made prior to the serving of a recall notice. However, where emergency action is needed representations will be allowed after the notice has been served. In addition, to the serving of any regulatory notice, MHRA has the discretion to prosecute the manufacturer. Appeals against conviction and/or sentence will take place in the courts.

2. Appeals procedure

Who may appeal?

Any manufacturer, authorised representative, supplier, distributor, and Notified Body subject to the Regulations.

Against what type of decision does there lie an appeal?

This document sets out the right of appeal when the following types of regulatory decision or action is being contemplated or taken against them.

1 The Medical Devices Regulations 2002
2 Consumer Protection Act 1987
3 General Product Safety Regulations 2005

It does not deal with complaints of an administrative nature. The handling of such complaints is described in the MHRA Code of Practice, copies of which are available on request from MHRA.

Value of the Independent Assessor

The MHRA's appeal procedure uses the independent adjudication system which forms part of the Government's initiative to promote a better and simpler regulatory framework. It is intended to provide speedy decisions at minimum cost to the parties involved with specified time limits for each stage. Time limits are designed to be fair but exacting; it is normally in the interests of all parties for a decision to be reached quickly.

An Independent Adjudicator (IA) is someone who has considerable experience in the health care sector but has no direct contact with or loyalty to the MHRA, the medical devices industry or any Notified Body when considering the decision taken by the MHRA.

MHRA's appeal procedure allows in appropriate cases for appeals to be referred to an IA.

3. How to Appeal

Medical Devices Regulations 2002

This section describes the appeal procedure attaching to each type of regulatory notice or action taken under the Medical Devices Regulations 2002 as detailed above.

a. Clinical investigation notifications
b. Notified Body designation
c. Notifications for the use of non-complying devices

These will be taken together as the procedure is the same for them all.

Once the Secretary of State (acting through the MHRA's Chief Executive) has taken his regulatory decision, the manufacturer has three months from the date of that decision or notice to notify the Chief Executive in writing that it wishes to appeal. If the request is sent after that three month period, the manufacturer should provide reasons for the delay. If those reasons seem justifiable, the request will be considered.

The Chief Executive will consider the basis upon which the regulatory decision was made and the case for the appeal then notify his decision to the manufacturer within four weeks of receiving the appeal notice. His decision will either be:

i. if he considers further investigation is needed, to refer the matter to an IA;

Where the Chief Executive refers the decision to an IA under i., the IA will investigate the matter being referred to him. The Chief Executive will then consider the IA's recommendations and inform the manufacturer of his final decision within four weeks of receiving the IA's recommendations. The IA's recommendations are not binding on the Chief Executive.

ii. if he does not consider that any further investigation is needed, to inform the manufacturer of the decision.

Where the Chief Executive decides that there is no need to refer the matter to an IA and makes a decision under ii., and the manufacturer is unhappy with that decision, it may request the Chief Executive to refer the matter to an IA. Such a request must be made within four weeks of receiving the Chief Executive's decision. Where the Chief Executive receives such a request, he will within four weeks of receiving that request refer the matter to the IA. The IA will investigate the matter and submit recommendations back to the Chief Executive within four weeks of the referral. The Chief Executive will then consider the recommendations and notify his final decision to the manufacturer within four weeks of having received the recommendation.

Prohibition notices, notices to warn and suspension notices

These are all notices under the Consumer Protection Act 1987. The rights to make representations in respect of prohibition notices and notices to warn are set out in Schedule 2 to the 1987 Act; the rights of appeal against suspension notices are set out in section 15 of the 1987 Act. In these cases the statutory procedure, and the supplemental provisions in the Regulations, will be followed rather than the MHRA's own administrative provisions.

Restriction notices

These may not, as yet, be issued in respect of active implantable medical devices. The procedure for appealing against restriction notices is the same as the appeals procedure against suspension notices (an appeal through the courts). Except in cases of emergency, companies will be given a right to make prior representations before restriction notices are issued.

Compliance Notices

The serving of Compliance Notice is an administrative direction by MHRA that the manufacturer must undertake certain actions in order to comply with the Medical Devices Regulations 2002. This will provide a time-limit as to when corrective action must have been completed by the manufacturer. In the event, the manufacturer has not instituted corrective steps as directed in the Compliance Notice, then further enforcement action will be taken. This can include prosecution and/or the serving of a regulatory notice as mentioned above. There is no right of appeal as a Compliance Notice has no immediate legal effect. However, where further enforcement action is contemplated, rights of appeal and/or representations is specified in the Consumer Protection Act 1987 and Medical Devices Regulations 2002.

General Product Safety Regulations 2005

This section describes the procedure for contesting a recall notice that has been served upon a distributor and/or supplier of medical devices that are consumer products as defined under the Regulations.

Recall notice

This is a notice under the General Product Safety Regulations 2005. Its effect is to compulsorily require a person to organise the return of unsafe products from consumers. MHRA will only serve a recall notice, where it has reasonable ground for believing that a product is a dangerous product, which has already been supplied and/or made available to consumers. The procedure for contesting a recall notice is to refer the matter to the Institute of Arbitrators for determination of the following questions (a) whether the product is a dangerous product and (b) whether the issue of a recall notice is proportionate to the seriousness of the risk posed by the respective product. The applicant will bear all fees, costs, and expenses for appointment and determination by the evaluator of the questions at both (a) and (b) and the advice given to the MHRA in connection with the serving of the recall notice. Copies of the procedure adopted by the Institute of Arbitrators is available on request.

There is a further right of appeal to vary or set aside a recall notice. The court may set aside a recall notice if (a) the product is not a dangerous product and (b) the procedure under Regulation 15(4) has not been complied with. In addition, where a recall notice has been served and a person proposes to make an application to set aside/vary a recall notice, he/she may within seven days from the date the notice has been served, apply to the court for an order to suspend a recall notice. There is a further right of appeal to Crown Court if a person is aggrieved against the making of an order concerning the above.

4. Further information

Further information can be obtained from our website under publications/regulatory guidance.

Telephone: 020 3080 6000
Email: era@mhra.gsi.gov.uk

Write:
Medicines and Healthcare products Regulatory Agency
5th Floor
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ