Regulation 35 Determining compliance of in vitro diagnostic medical devices with relevant essential requirementsE1
England, Wales and Scotland
In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.
In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English F1... .
A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant F2designated standard.
A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.
Annotations
Textual amendments
- F1
Words in reg. 35(2) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 37); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in reg. 35(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 37); 2020 c. 1, Sch. 5 para. 1(1)
Extent
- E1
This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only