1.Where manufacturers provide the instructions for use in electronic form on an electronic storage medium together with the device or where the device itself is fitted with a built-in system visually displaying the instructions for use, the instructions for use in electronic form shall also be made accessible to the users through a website.
2.Any website containing instructions for use of a device which are provided in electronic form instead of in paper form shall comply with the following requirements:
(a)the instructions for use shall be provided in a commonly used format that can be read with freely available software;
(b)it shall be protected against hardware and software intrusion;
(c)it shall be provided in such a way that the server downtime and display errors are reduced as far as possible;
(d)it shall mention in which Union languages the manufacturer provides the instructions for use in electronic form;
(e)it shall fulfil the requirements of [F1the Data Protection Act 2018 and the UK GDPR];
(f)the Internet address as displayed in accordance with Article 6(2) shall be stable and directly accessible during the periods set out in points (9) and (10) of Article 5;
(g)all previous versions of the instructions for use issued in electronic form and their date of publication shall be available on the website.
[F23.In this Article “the UK GDPR” has the same meaning as in Parts 5 to 7 of the Data Protection Act 2018 (see section 3(10) and (14) of that Act).]
Textual Amendments
F1Words in Art. 7(2)(e) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 6(a)
F2Art. 7(3) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 6(b)