Article 1
In this Regulation a reference to an Annex to
Directive 90/385/EEC
or to an Annex to
Directive 93/42/EEC
is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A to the Medical Devices Regulations 2002.
This Regulation establishes the conditions under which the instructions for use of medical devices referred to in point 15 of Annex 1 to Directive 90/385/EEC and in point 13 of Annex I to Directive 93/42/EEC may be provided in electronic form instead of in paper form.
It also establishes certain requirements concerning instructions for use in electronic form which are provided in addition to complete instructions for use in paper form relating to their contents and websites.
Words in Art. 1 inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 4