The Medical Devices (Amendment) Regulations 2008

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Medical Devices Regulations 2002 (“the principal Regulations”), to implement Directive 2007/47/EC of the European Parliament and of the Council(1).

The principal Regulations contain the legislative measures necessary for the implementation of the European Community scheme for regulating the placing on the market and putting into service of medical devices, including Council Directive 90/385/EEC concerning active implantable medical devices(2) and Council Directive 93/42/EEC concerning medical devices(3), as amended(4), which are amended by Directive 2007/47/EC.

Regulation 2 amends the principal Regulations with regard to the definitions of a medical device, a custom made device, intended purpose of a device, authorised representatives and clinical data.

Regulation 3 amends regulation 3 of the principal Regulations so as to provide that the Regulations apply to medical devices if they incorporate products made up of tissues or cells of human origin as an ancillary product. Regulation 3 also lists the products exempt from the provisions of Directive 90/385/EC to bring this in line with those set out in Directive 93/42/EC.

Regulation 4 amends regulation 5 of the principal Regulations to include reference to a duly qualified healthcare practitioner writing prescriptions for custom-made devices for the sole use of particular patients.

Regulations 5 and 12 amend regulation 6 and 21 of the principal Regulations to include a new requirement to apply the relevant health and safety requirements of Directive 2006/42/EC of the European Parliament and of the Council on machinery(5) for medical devices and active implantable devices that fall within the definition of a machine.

Regulation 6 amends regulation 9 of the principal Regulations making provisions concerning the supply of information to patients. Regulation 6 also sets out the application of protective personal equipment requirements under Council Directive 89/686/EEC(6) when a medical device has this dual purpose.

Regulation 7 amends regulation 14 of the principal Regulations, to specify which Annexes contain the relevant sterility procedures for this regulation.

Regulation 8 amends regulation 15 of the principal Regulations to ensure that the statement required for custom made devices is passed on to allow a patient access to it.

Regulations 9(a), 10 and 11 amend regulations 16, 18 and 19 of the principal Regulations respectively, in changing the conformity assessment and notification procedure. Regulations 9(b) and 13 amend regulation 29 of the principal Regulations to extend the new notification provisions now required for the end of a clinical investigation and justification where there has been early termination.

Regulation 14 amends regulation 30 of the principal Regulations to require that addresses of manufacturers be notified to the Secretary of State, along with details of their devices and labels, and for those who do not have a registered place of business in a Member State, designating a single authorised representative who must have a registered place of business within a Member State.

Regulations 15 and 16 amend regulation 31 of the principal Regulations to extend the application of Annex 5 as a relevant procedure within this regulation and to bring active implantable medical devices in line with general medical devices as far as conformity procedures are concerned. Regulation 18 amends regulation 63 of the principal Regulations to bring active implantable medical devices into line with other medical devices as far as restriction notices are concerned.

A full impact assessment of the effect that this instrument will have on the costs of business, and a Transposition Note in relation to the implementation of Directive 2007/470/EC, are available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

(1)

OJ No. L247, 21/9.2007, p.21.

(2)

Council Directive 90/385/EEC has been amended by Directive 93/42/EEC (OJ No. L169, 12.7.1993, p.1), Directive 93/68/EEC (OJ No. L220, 30.8.93, p.1) and Regulation (EC) No. 1882/2003 (OJ No. L284, 31.10.2003, p.1).

(3)

Council Directive 93/42/EEC has been amended by Directive 98/79/EC (OJ No. L331, 7.12.98, p.1), Directive 2000/70/EC (OJ No. L313, 13.12.2000, p.22), Directive 2001/104/EC (OJ No. L6, 10.1.2002), p.50) and Regulation (EC) No. 1882/2003 (OJ No. L284, 31.10.2003, p.1).

(4)

Directive 2007/47/EC.

(5)

OJ No. L157, 9.6.2006, p.24.

(6)

Council Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment (OJ No. L399, 30.12.1989, p.18), as last amended by Regulation (EC) No. 1882/2003 (OJ No. L284, 31.10.2003, p.1).