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The Medical Devices Regulations 1994

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Registration of persons placing devices on the market

14.—(1) A manufacturer with a registered place of business in the United Kingdom who, under his own name, places a device on the market in accordance with the procedures referred to in regulation 7 or regulation 15(1) shall—

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

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

(2) Any person with a registered place of business in the United Kingdom who is engaged in the activities referred to in regulation 11 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 to which that regulation applies which are sufficient to identify them.

(3) Any person with a registered place of business in the United Kingdom who places on the market a device referred to in paragraph (1) on behalf of a manufacturer who does not have a registered place of business in the Community shall inform the Secretary of State of—

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

(b)the category of device.

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