PART III

Active Implantable Medical Devices

Scope of Part III
21
1
The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, ...
2
Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in
Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008
to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.
3
Where an active implantable device is intended to administer a medicinal product, that device must be governed by this Part without prejudice to the provisions of the Human Medicines Regulations 2012.
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scope of Part III
21
1
The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, except for devices that come within the scope of Directive 90/385 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and
a
the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it; and
b
the manufacturer chooses to follow the set of arrangements in the other Directive.
2
Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.
3
Where an active implantable medical device is intended to administer a medicinal product, that device shall be governed by Directive 90/385 without prejudice to the provisions of Directive
2001/83/
EC
.
Reg. 21(2)(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(b)
Reg. 21(3) substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 11(b)
Words in reg. 21(1) omitted (E.W.S) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 11(a)
Reg. 21(4) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 11(c)
Reg. 21 renumbered as reg. 21(1) (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(a)
Words in reg. 21(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(2)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Reg. 21 renumbered as reg. 21(1) (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(a)
Reg. 21(2)(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(b)