Volume 7: Medicines and Cosmetics
2. The operation of medicines licensing
Regulation of medical devices
Responsibilities
Ensuring safety of medical devices

Responsibilities

2.113 We noted above that medical devices such as heart valves and pacemakers fell outside the controls of the Medicines Act. When BSE first emerged, they were the responsibility of the Supplies Technology Division of the NHS Procurement Directorate (PD/STD) of DH. From 1 August 1990 the Medical Devices Directorate (MDD) took over this responsibility.

2.114 Eventually, in 1994, medical devices became the responsibility of the Medical Devices Agency (MDA), an executive agency of DH. 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, met appropriate standards of safety, quality and performance and that these standards complied with the relevant Directives of the EU. ¹

2.115 As noted in paragraph 2.37, PD/STD and its successors also had responsibility for administering product licences held on behalf of the Secretary of State for Health. This function was moved elsewhere in DH in August 1992. ²

2.116 Within PD/STD three areas had relevant responsibilities so far as BSE was concerned. These were: implants; sterilisation; and the Manufacturer Registration Scheme (MRS) (see paragraph 2.22). Miss Marilyn Duncan headed both the implants and sterilisation areas, first as a Grade 6 and then as a Grade 5. ³ The other person who had significant involvement in the BSE story in relation to medical devices was Mr Will Burton, a Principal Pharmaceutical Officer in STD.

Ensuring safety of medical devices

2.117 Some medical devices, such as sutures, were expressly brought within the controls of the Medicines Act, by statutory instruments (see paragraph 2.8). They were dealt with under the regime we have described above.

2.118 Those that were not brought within the scope of the Medicines Act were simply covered by general product safety legislation. If there was a need to remove an unsafe medical device from the UK market, powers under the Consumer Protection Act 1987 ⁴ were the appropriate means of doing so.

2.119 However, PD/STD (and later the MDD) did operate a voluntary MRS on which there were no statutory controls. Purchasers of medical devices (mainly the NHS) were advised to buy them only from manufacturers registered on the scheme. A member of the MRS failing to meet the requirements of the scheme could be removed from the register. A reporting system also operated to encourage manufacturers and users to report details of any adverse incidents involving medical devices. ⁵

2.120 Separate regulation of medical devices began on 1 January 1993. ⁶ Regulations were then introduced which applied to active implants (ie, relying on a source of power other than that generated by the human body or gravity), partial or whole, left in the body, including pacemakers. ⁷

2.121 Regulation of other devices (with some exceptions) was introduced in 1994. ⁸

2.122 Enforcement of these provisions in the UK is the responsibility of the Secretary of State for Health, acting through the MDA. Local authorities have some enforcement responsibilities for medical devices that are also consumer goods. The MDA's duties include ensuring compliance and evaluating adverse incident reports provided by manufacturers and users under a statutory duty. ⁹ The Regulations provide for a vigilance system whereby information concerning serious incidents in the UK must be notified by the MDA to the EU and other Member States, so that any necessary action can be taken at European level. ¹⁰

2.123 Independent accreditation bodies, known as Notified Bodies, check manufacturers' claims of conformity for everything except the lowest-risk devices. These bodies are monitored by the MDA. ¹¹