The Medical Devices Regulations 1994

Introductory Text
1.Citation and commencement
2.Interpretation
3.Application of Regulations
4.Classification of devices
5.Essential requirements for devices
6.CE marking
7.Procedure for affixing CE marking for Class I devices
8.Procedure for affixing CE marking for Class IIa devices
9.Procedure for affixing CE marking for Class IIb devices
10.Procedure for affixing CE marking for Class III devices
11.Procedure for systems and procedure packs, and devices to be sterilised before use
12.General provisions relating to conformity assessment procedures
13.Obligations of persons other than manufacturers
14.Registration of persons placing devices on the market
15.Custom-made devices
16.Clinical investigations
17.Notified bodies
18.Prohibition on supply etc.
19.Enforcement etc.
20.Centralised system of records etc.
21.Fees
22.Transitional provisions
23.Notification of decisions etc.
24.Amendment of Schedule 1 to the Provision and Use of Work Equipment Regulations 1992
25.Substitution for Schedule 1 to the Personal Protective Equipment at Work Regulations 1992
26.Amendment of the Clinical Thermometers (EEC Requirements) Regulations 1993
27.Amendment of the Electro-medical Equipment (EEC Requirements) Regulations 1988
Signature
Explanatory Note