The Medical Devices Regulations 2002

Registration of persons placing general medical devices on the market

19.—(1) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person to whom this paragraph applies shall—

(a)inform the Secretary of State of the address of his registered place of business; and

(b)supply the Secretary of State with a description of each category of device concerned.

(2) Paragraph (1) applies to—

(a)a manufacturer with a registered place of business in the United Kingdom who, under his own name, places on the market in the United Kingdom a relevant device which is a Class 1 device or a custom-made device, other than a system or procedure pack which is not CE marked; and

(b)a person with a registered place of business in the United Kingdom who sterilises before use relevant devices designed by their manufacturer to be sterilised before use.

(3) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a device mentioned in paragraph (2) on the market in the United Kingdom on behalf of a manufacturer who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement shall inform the Secretary of State of—

(a)the address of his registered place of business;

(b)the category of device; and

(c)in the case of an authorised representative of the manufacturer, the fact that he is the manufacturer’s authorised representative, and he shall furnish the Secretary of State with sufficient evidence that he is an authorised representative of the manufacturer.

(4) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a system or procedure pack which is not CE marked on the market in the United Kingdom, or who sterilises systems or procedure packs before they are placed on the market, shall—

(a)inform the Secretary of State of the address of that registered place of business; and

(b)supply the Secretary of State with descriptions of the devices which are included in any such system or procedure pack in a manner sufficient to identify them.

(5) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a relevant device which is a Class IIb or III device on the market in the United Kingdom (including the authorised representative of a manufacturer of a Class IIb or III device who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement) shall, if the Secretary of State so requests, supply the Secretary of State with all data allowing for the identification of the device together with the label and the instructions for use for when the device is put into service within the United Kingdom.

(6) Registration under this regulation is not required if—

(a)the device or pack was first placed on the market in a State which is a Party to an Association Agreement (if that Agreement contains measures relating to the mutual recognition of the results of conformity assessment undertaken in respect of that device); and

(b)the manufacturer or his authorised representative has already registered with the competent authorities of that State.