Regulation 6 Scope of Part II
United Kingdom
The requirements of this Part in respect of relevant devices apply in respect of medical devices (including stable derivatives devices), accessories to such devices, single-use combination products, and systems and procedure packs, other than—
active implantable medical devices and accessories to such devices; F1and
in vitro diagnostic medical devices and accessories to such devices; F2and
F3devices that come within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and
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
the manufacturer chooses to follow the set of arrangements in the other Directive.
Annotations
Textual amendments
- F1
Word in reg. 6(a) inserted (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. 8(a)
- F2
Word in reg. 6(b) 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. 8(b)
- F3
Reg. 6(c) 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. 8(c)