http://www.legislation.gov.uk/uksi/1992/3146/introduction/made
The Active Implantable Medical Devices Regulations 1992
Health and safety requirements
King's Printer of Acts of Parliament
2015-02-25
CONSUMER PROTECTION
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 Active Implantable Medical Devices Regulations 1992
Instrument
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.3
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defn. of authorised representative)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(2)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defn. of EC mark)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(3)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defns. of CE marking and the Community)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(3)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defn. of the EEA Agreement)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(4)
The Active Implantable Medical Devices Regulations 1992
reg.2(01) (defn. of harmonised Standard)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(5)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defn. of manufacturer)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(6)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defn. of member State)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(7)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defn. of placed on the market)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(8)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defn. of placing on the market)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(8)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) defn.of ( relevant national Standard) para.(c)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(9)
The Active Implantable Medical Devices Regulations 1992
reg.2(1) (defn. of relevant notified body logo)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.2(10)
The Active Implantable Medical Devices Regulations 1992
reg.3(4)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.4
The Active Implantable Medical Devices Regulations 1992
reg.4(1)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.5(2)
The Active Implantable Medical Devices Regulations 1992
reg.4(1)(b)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.5(3)
The Active Implantable Medical Devices Regulations 1992
reg.4(3)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.5(4)
The Active Implantable Medical Devices Regulations 1992
reg.4(4)-(7)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.5(5)
The Active Implantable Medical Devices Regulations 1992
reg.5(2)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.6(2)
The Active Implantable Medical Devices Regulations 1992
reg.5(2)(c)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.6(3)
The Active Implantable Medical Devices Regulations 1992
reg.5(4)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.6(4)
The Active Implantable Medical Devices Regulations 1992
reg.5(5)
reg.5(5)(d)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.6(5)
The Active Implantable Medical Devices Regulations 1992
reg.5(6A)-(6F)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.6(6)
The Active Implantable Medical Devices Regulations 1992
reg.7(2)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.7(2)
The Active Implantable Medical Devices Regulations 1992
reg.7(2A)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.7(3)
The Active Implantable Medical Devices Regulations 1992
reg.7A
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg. 8
The Active Implantable Medical Devices Regulations 1992
reg.8(6)
(7)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.9
The Active Implantable Medical Devices Regulations 1992
reg.9(1)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.10(2)
The Active Implantable Medical Devices Regulations 1992
reg.9(2)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.18
The Active Implantable Medical Devices Regulations 1992
reg.9(2)(b)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.10(3)
The Active Implantable Medical Devices Regulations 1992
reg.9(4)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.10(4)
The Active Implantable Medical Devices Regulations 1992
regs.10A
10B
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.11
The Active Implantable Medical Devices Regulations 1992
reg.12(1A)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.12(2)
The Active Implantable Medical Devices Regulations 1992
reg.12(2)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.12(3)
The Active Implantable Medical Devices Regulations 1992
Sch.1
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.13
Sch.
The Active Implantable Medical Devices Regulations 1992
Sch.3
para.1(1)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.14
The Active Implantable Medical Devices Regulations 1992
Sch.5
para.2(1)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.15(2)
The Active Implantable Medical Devices Regulations 1992
Sch.5
para.3(4)(b)(ii)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.15(3)
The Active Implantable Medical Devices Regulations 1992
Sch.5
para.10(4)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.15(4)
The Active Implantable Medical Devices Regulations 1992
Sch.5
para.10(5)
(6)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.15(5)
The Active Implantable Medical Devices Regulations 1992
Sch.6
para.7
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.16(2)
The Active Implantable Medical Devices Regulations 1992
Sch.6
para.8(2)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.16(3)
The Active Implantable Medical Devices Regulations 1992
Sch.6
paras.9
10
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.16(4)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.1
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(2)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.1A
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(3)
The Active Implantable Medical Devices Regulations 1992
Sch. 7
para.2(2)(a)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(4)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.3(1)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(5)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.4(1)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(6)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.4(4)(b)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(7)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.4(5)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(8)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.4(6A)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(9)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.4(7)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(10)
The Active Implantable Medical Devices Regulations 1992
Sch.7
para.4(8)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
reg.17(11)
The Active Implantable Medical Devices Regulations 1992
Sch. 2
para. 10
The Medicines (Codification Amendments Etc.) Regulations 2002
reg. 6(a)
reg. 1(1)
The Active Implantable Medical Devices Regulations 1992
Sch. 2
para. 10
The Medicines (Codification Amendments Etc.) Regulations 2002
reg. 6(b)
reg. 1(1)
The Active Implantable Medical Devices Regulations 1992
Regulations
The Medical Devices Regulations 2002
reg. 66(a)
reg. 1
1992 No. 3146
CONSUMER PROTECTION
The Active Implantable Medical Devices Regulations 1992
Made
Laid before Parliament
Coming into force
The Secretary of State, in exercise of the powers conferred by sections 11 and 27(2)(b) of the Consumer Protection Act 19871, after consultation in accordance with section 11(5) of that Act with organisations appearing to her to be representative of interests substantially affected by these Regulations, with such other persons as appear to her to be appropriate and with the Health and Safety Commission, and the Secretary of State as respects Great Britain and the Department of Health and Social Services for Northern Ireland as respects Northern Ireland, in exercise of the powers conferred by section 2(2) of the European Communities Act 19722 and in each case in exercise of all other powers so enabling them, hereby make the following Regulations:—