PART IIIU.K.Active Implantable Medical Devices

[F1UK(NI) indication: active implantable medical devicesN.I.

24A.—(1) Where the CE marking referred to in regulation 24 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a)visibly, legibly and indelibly; and

(b)before a relevant medical device is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 27.

[F2(3A) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.]

(4) The UK(NI) indication must be affixed by the manufacturer.

(5) Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

(6) No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service”;]

Textual Amendments