PART IIU.K.General Medical Devices

Essential requirements for general medical devicesE+W+S

8.—(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.]

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Essential requirements for general medical devicesN.I.

8.—(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 [F5and 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 [F6and the requirements set out in Regulation (EU) No 722/2012 (if applicable)].

[F7(3) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to Directive 2006/42 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.]

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments