Regulation 22 Essential requirements for active implantable medical devices

(1)

Subject to regulation 26, 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 1 which apply to it F1and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

(2)

Subject to regulation 26, 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 also been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex 1 which apply to it F2and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

Annotations

Textual amendments

F1: Words in reg. 22(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 10
F2: Words in reg. 22(2) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 10