The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995

Explanatory Note

(This note is not part of the Regulations)

These Regulations (“the Regulations”) amend the Active Implantable Medical Devices Regulations 1992 (“the principal Regulations”) which implement Council Directive 90/385/EEC (OJ No. L 189, 20.7.90, p. 17) (“the active implantable medical devices Directive”). The Regulations implement those provisions in Council Directive 93/42/EEC (OJ No. L 169, 12.7.93, p. 1) (“the medical devices Directive”) which amend the active implantable medical devices Directive. The Regulations also implement in part Council Directive 93/68/EEC (OJ No. L 220, 30.8.93, p. 1) (“the CE marking Directive”) which amends a series of directives on technical harmonisation and standards which includes the active implantable medical devices Directive. The Regulations also make certain other minor amendments to the principal Regulations.

Regulation 2 amends certain definitions in the principal Regulations and introduces new definitions.

Regulation 3 substitutes for the term “EC mark” wherever it occurs in the principal Regulations the term “CE marking”.

Regulation 4 amends regulation 3(4) of the principal Regulations which specifies the language which must be used on the packaging etc. of a device.

Regulation 5 introduces amendments to regulation 4 which concern the CE marking and which are required under the CE marking Directive.

Regulation 6 introduces amendments to regulation 5 required under both the medical devices Directive and the CE marking Directive. The amendments concern the conformity assessment procedures to be carried out in order that the CE marking may be affixed to devices.

Regulation 7 amends the provisions on clinical investigations in regulation 7 of the principal Regulations. The amendments introduce a new provision whereby the Secretary of State may authorise a clinical investigation to take place before the 60 day period referred to in regulation 7(1) of the principal Regulations has elapsed.

Regulation 8 introduces new regulation 7A which sets out the obligations of persons other than manufacturers.

Regulation 9 amends regulation 8 of the principal Regulations on notified bodies. New provisions are introduced under which the Secretary of State may refuse to designate or may withdraw designation from bodies when certain fees are not paid. The amendments also provide that the Secretary of State may inspect certain premises etc. for the purposes of carrying out her functions in relation to notified bodies.

Regulation 10 amends the provisions in regulation 9 of the principal Regulations on prohibition on supply etc..

Regulation 11 introduces new regulations 10A and 10B. Regulation 10A deals with enforcement. It provides for a two stage procedure to be used in cases in which the Secretary of State has reasonable grounds for believing that the CE marking has been wrongly affixed to a device which she does not consider to be unsafe.

Regulation 12 amends the provisions in regulation 12 of the principal Regulations on notification of decisions etc..

Regulation 13 substitutes a new Schedule 1 to the principal Regulations. This Schedule illustrates the CE marking and contains requirements as to its dimensions etc..

Regulation 14 introduces amendments to Schedule 3 to the principal Regulations which deals with the evaluation of clinical data.

Regulations 15, 16 and 17 amend Schedules 5, 6 and 7 respectively to the principal Regulations. These Schedules set out the conformity assessment procedures to be followed by manufacturers.

Regulation 18 contains a transitional provision required under the CE marking Directive.

A compliance cost assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies of the assessment are also available from the Medical Devices Agency, 11th Floor South, Hannibal House, Elephant and Castle, London, SE1 6TQ.