UK Offence Report

The Active Implantable Medical Devices Regulations 1992

UK Statutory Instrument 1992 No. 3146 — creates 1 criminal offence.

1offences created
0recorded in force
1revoked
Made
10 December 1992
In force from
1 January 1993
Extent
Not stated
Subject
Food, consumer protection, trading standards, product safety and age-restricted sales
Made under
Consumer Protection Act 1987, European Communities Act 1972

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations (“the Regulations”) implement Council Directive 90/385/EEC (“Directive”) on the approximation of the laws of the Member States relating to active implantable medical devices (OJ No. L189, 20.7.90, p. 17). The Directive is based on the Council resolution of 7 May 1985 on a new approach to technical harmonisation and standards (OJ No. C136, 4.6.85, p. 1). It lays down essential safety requirements which active implantable medical devices (“devices”) must satisfy. Regulation 3 provides that devices placed on the market or put into service must comply with the relevant essential requirements (set out in Schedule 2) and sets out the factors to be taken into consideration in deciding whether the device meets the essential requirements. Regulation 4 requires devices other than custom-made devices or devices intended for clinical investigation to bear the EC mark. Regulation 4 also prohibits the use of a mark which is likely to be confused with the EC mark. Regulation 5 provides that a device may bear the EC mark only if its manufacturer— a follows the EC declaration of conformity procedure as set out in Schedule 5 or b follows the EC type-examination procedure as set out in Schedule 6, together with i the EC verification procedure as set out in Schedule 7, or ii the EC declaration of conformity to type procedure as set out in Schedule 8. Regulation 6 and Schedule 4 contain rules in respect of custom-made devices. Regulation 7 and Schedule 4 contain rules in relation to devices intended for clinical investigation. Regulation 8 provides for the approval of notified bodies to carry out tasks in relation to regulation 5 and Schedule 9 sets out the conditions which notified bodies must meet. Regulation 5(8) to (11) makes provision for the fees chargeable by the notified bodies for work done under the Regulations. Regulation 9 creates offences and regulation 10 provides that the Regulations are to be regarded for the purposes of enforcement as safety regulations and safety provisions as defined in the Consumer Protection Act 1987, although they are made partly in exercise of other powers. Transitional provisions are provided for in regulation 11. Regulation 12 provides for the notification of decisions by the Secretary of State and the notified body.

Offences created by this instrument

What Parliament said about it

Hansard was searched for this instrument by name and returned nothing. That is the ordinary outcome: an instrument laid under the negative procedure is usually never debated, and becomes law without a word said about it in either House.

How Parliament handled it

Parliament's Statutory Instruments service records procedure from May 2017 onwards, and this instrument predates it. That is a limit of the source, not a statement that nothing happened.

Check the source