The In Vitro Diagnostic Medical Devices Regulations 2000

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (“ the Directive”).

Regulation 2 is an interpretation provision. Regulation 3 sets out the scope of the Regulations, and indicates which in vitro diagnostic medical devices are covered by the Regulations (“relevant devices”). Regulation 4 provides that relevant devices placed on the market, put in to service or (in certain circumstances) supplied must comply with the relevant essential requirements, as defined by reference to the essential requirements specified in Annex I of the Directive. Regulation 4 also sets out the factors to be taken into consideration when deciding whether a relevant device meets the essential requirements.

Regulation 5 requires relevant devices, their instructions for use and their sales packaging to bear a CE marking which meets the requirements of the Directive. Regulation 6 deals with the CE marking of relevant devices that come within the scope of more than one Directive, and regulation 7 contains prohibitions relating to relevant devices which are not ready for use.

Regulation 8 specifies exemptions from the requirements of regulations 4, 5 and 7, including exemptions in the interests of the protection of health. Regulation 9 sets out the procedures which manufacturers must follow for affixing the CE marking to relevant devices, and regulation 10 contains supplemental provisions relating to those procedures, including a number of additional requirements on manufacturers or their authorised representatives.

Regulation 11 creates prohibitions relating to the affixing of a CE marking for a relevant device to a product which is not a relevant device. Regulation 12 specifies, by reference to Annex VIII of the Directive, the rules in respect of making available devices for performance evaluation.

Regulations 13 and 14 relate to the registration of manufacturers, or their authorised representatives, of relevant devices and devices for performance evaluation, and the information they need to supply to the Secretary of State for registration purposes.

Regulation 15 deals with the designation of United Kingdom notified bodies and the circumstances in which such designations may be varied and withdrawn. Regulation 16 specifies the functions of such bodies. Regulation 17 makes provision for the fees chargeable by the notified bodies for work done in connection with the conformity assessment procedures set out in the Annexes to the Directive.

Regulation 18 specifies the responsibilities for enforcement in relation to the Regulations, and it provides that the Regulations are to be regarded for the purposes of enforcement as safety regulations as defined in the Consumer Protection Act 1987, although they are made partly in exercise of other powers. It also designates the Secretary of State as responsible for certain public health monitoring activities.

Regulation 19 contains a notice procedure for requiring compliance where there is a failure to comply with the requirements of the Regulations, and a further notice procedure for applying restrictions to the availability of devices where this is necessary to ensure the protection of health or safety.

Regulation 20 contains transitional provisions, and regulation 21 contains procedural requirements in relation to the notification of decisions by the Secretary of State, other enforcement authorities and the United Kingdom notified bodies.

Regulation 22 gives effect to Schedule 1 which contains amendments to the Medical Devices Regulations 1994 which are consequential upon amendments to Council Directive 93/42/EEC concerning medical devices(1) that were included in the Directive. The changes to Council Directive 93/42/EEC were essentially to align the requirements of the two Directives. Some additional changes have also been made to the 1994 Regulations to align the implementation approach adopted in those Regulations with the approach adopted in these Regulations, and there are also changes to the system set out in the 1994 Regulations for obtaining the approval of ethics committees and the Secretary of State for proposed clinical investigations.

Regulation 23 gives effect to Schedule 2 which contains amendments to the Medical Devices Fees Regulations 1995 arising out of both the new scheme for in vitro diagnostic medical devices and the scheme in the Medical Devices Regulations 1994. There are new fees in connection with the registration scheme for relevant devices and devices for performance evaluation, as well as a new fee in connection with the registration scheme for certain medical devices. Notified bodies are also required to pay fees in relation to their designation scheme, and for certain inspections by the Secretary of State. The amendments also include some new enforcement provisions for the 1995 Regulations.

A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1 6TQ.

(1)

O.J. No. L169, 12.7.1993, p. 1.