Regulation 8 Essential requirements for general medical devicesE1

England, Wales and Scotland

(1)

Subject to regulation 12, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it F1and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

(2)

Subject to regulation 12, no person shall supply a relevant device—

(a)

if that supply is also a placing on the market or putting into service of that device; or

(b)

in circumstances where that device has been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex I which apply to it F2and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

F3(3)

Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in F4Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.

Annotations

Textual amendments

F1: Words in reg. 8(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3
F2: Words in reg. 8(2) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3
F3: Reg. 8(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 5
F4: Words in reg. 8(3) substituted (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), 4(5) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 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