Volume 14: Responsibilities for Human and Animal Health
7. Human and veterinary medicines and cosmetics
Medical devices
Responsibilities
Statutory controls
Non-statutory controls

Responsibilities

7.98 Until 1990, the regulation of medical devices was the responsibility of the Supplies Technology Division of the NHS Procurement Directorate. From 1 August 1990, this passed to the Medical Devices Directorate, which was re-organised into the Medical Devices Agency (MDA), an Executive Agency of DH established in September 1994. It had responsibility on behalf of the Secretary of State for Health for taking all reasonable steps to ensure that medical devices in the UK were of safe design and met appropriate standards of safety, quality and performance and that these standards complied with the relevant Directives of the EU. This involved:

1. ensuring compliance with relevant regulations;
2. evaluating adverse incident reports received from manufacturers and users;
3. assessing notifications for clinical investigations; and
4. designating and monitoring independent accreditation bodies (Notified Bodies) used to check manufacturer's claims of conformity for all but the lowest risk devices. ¹

Statutory controls

7.99 Medical devices were excluded from the licensing system governing medicinal products. They were covered by the general product safety regime of the Consumer Protection Act 1987. This Act, which is described in more detail in the section on Cosmetics below, provided powers to prohibit the supply of consumer goods, defined as 'goods . . . ordinarily intended for private use or consumption', and to remove unsafe products. The Act contained enforcement powers for the Regulations made under it. There was also European legislation.

7.100 From 1992 onwards, several sets of Regulations were introduced under the Consumer Protection Act, including some providing specifically for medical devices. The Active Implantable Medical Devices Directive 90/385/EEC was implemented in the UK by the Active Implantable Medical Devices Regulations 1992. ² These Regulations applied to active implants (ie, relying on a source of power other than that generated by the human body or gravity), totally or partially introduced into the human body and intended to remain there, including pacemakers. ³ Separate regulation of most other medical devices began with the Medical Devices Directive 93/42/EEC, as implemented in the UK by the Medical Devices Regulations 1994. ⁴ These Regulations provided that medical devices placed on the market must comply with certain essential requirements in relation to safety and performance. ⁵

7.101 Manufacturers had a statutory responsibility to report serious adverse incidents involving medical devices. The Regulations also provided for a vigilance system whereby information concerning serious incidents in the UK had to be notified by the MDA to the EU and other Member States, so that any necessary action could be taken at European level. Member States had the power to withdraw from their market any product considered to be a danger to public health. ⁶ From 1994, medical devices were also subject to the General Product Safety Regulations 1994, under which offences might be committed by the marketing of unsafe goods.

7.102 Powers under the Consumer Protection Act were exercisable by the Secretary of State for Health. The Secretary of State was also the responsible authority for enforcing the EC Directives on medical devices in the UK, acting through the MDA, although local authority Trading Standards Departments had some enforcement responsibilities for medical devices that were also consumer goods.

Non-statutory controls

7.103 In addition to the general product safety legislative regime outlined above, the MDA and its predecessors ran a voluntary registration scheme - the Manufacturers' Registration Scheme (MRS) - under which manufacturers could apply for assessment of their quality systems for the manufacture of medical devices, and subsequent registration. The manufacturing practices and quality systems of those who chose to register were evaluated and audited. The MRS was run down gradually as the product-specific statutory provisions for the regulation of medical devices described above were introduced, and the scheme was ended in 1998.

7.104 Although voluntary, this registration scheme served as a control. Purchasers, mainly the NHS, were advised to buy medical devices and equipment only from MRS-registered manufacturers. The Inquiry was told that the MDA believed that this advice was followed in the vast majority of cases. ⁷ Further, manufacturers would be removed from the MRS if their systems and practices failed to meet the requirements of the scheme.

7.105 Another control was a reporting system, operated by the MDA, to encourage manufacturers and users to notify details of any adverse incidents involving medical devices. On the basis of reports received, the MDA issued safety and hazard notices to users of medical devices to alert them to any potential problems or safety issues. ⁸

7.106 In addition, the MDA operated other information controls including surveys, issuing guidance, performing audits and maintaining other contacts with the industry. ⁹