Article 3U.K.
1.Subject to the conditions set out in paragraph 2, manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices:
(a)active implantable medical devices and their accessories covered by [F1Part 3 of the Medical Devices Regulations 2002] intended to be used exclusively for the implantation or programming of a defined active implantable medical device;
(b)implantable medical devices and their accessories covered by [F2Part 2 of the Medical Devices Regulations 2002] intended to be used exclusively for the implantation of a defined implantable medical device;
(c)fixed installed medical devices covered by [F3Part 2 of the Medical Devices Regulations 2002];
(d)medical devices and their accessories covered by [F4Part 3 or Part 2 of the Medical Devices Regulations 2002] fitted with a built-in system visually displaying the instructions for use;
(e)stand-alone software covered by [F5Part 2 of the Medical Devices Regulations 2002].
2.Manufacturers may provide instructions for use in electronic form instead of in paper form for the devices listed in paragraph 1 under the following conditions:
(a)the devices and accessories are intended for exclusive use by professional users;
(b)the use by other persons is not reasonably foreseeable.
Textual Amendments
F1Words in Art. 3(1)(a) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 5(a)
F2Words in Art. 3(1)(b) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 5(b)
F3Words in Art. 3(1)(c) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 5(b)
F4Words in Art. 3(1)(d) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 5(c)
F5Words in Art. 3(1)(e) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 5(b)