Statutory Instrument 1992 No. 3146

The Active Implantable Medical Devices Regulations 1992

(The document as of February, 2008)

-- Back --

STATUTORY INSTRUMENTS

1992 No. 3146

CONSUMER PROTECTION

The Active Implantable Medical Devices Regulations 1992

Made	10th December 1992

Laid before Parliament

11th December 1992

Coming into force

1st January 1993

ARRANGEMENT ARRANGEMENT OF REGULATIONS

1.	Citation and commencement
2.	Interpretation
3.	Essential requirements for devices
4.	EC mark
5.	Procedure for affixing EC mark
6.	Custom—made devices
7.	Clinical investigations
8.	Notified bodies
9.	Prohibition on supply etc.
10.	Enforcement etc.
11.	Transitional provision
12.	Notification of decisions etc.

SCHEDULES
	1.	EC mark
	2.	Essential requirements for active implantable medical devices (corresponding to Annex 1 of the Directive)
	3.	Evaluation etc. of clinical data (corresponding to Annex 7 of the Directive)
	4.	Conditions relating to devices for special purposes (corresponding to Annex 6 of the Directive)
	5.	EC declaration of conformity procedure (corresponding to Annex 2 of the Directive) —
	Part I—Quality system
	Part II—Surveillance
	6.	EC type—examination procedure (corresponding to Annex 3 of the Directive)
	7.	EC verification procedure (corresponding to Annex 4 of the Directive)
	8.	EC declaration of conformity to type procedure (corresponding to Annex 5 of the Directive) —
	Part I—Quality system
	PartII—Surveillance
	9.	Notified bodies — condition

-- Back --