14 Amendment of regulation 30 of the principal Regulations
In regulation 30 of the principal Regulations (manufacturers and conformity assessment procedures for active implantable medical devices), after paragraph (2), add—

“3 Except as provided in paragraphs (4) and (5), the manufacturer of a relevant device, who under their own name places devices on the market, in accordance with the procedure referred to in Article 9(2) of Directive 90/385, shall provide the Secretary of State with—
(a) the address of their registered place of business;
(b) a description of the devices concerned; and
(c) details of the label and instructions for use that accompany each device.
4 Where the manufacturer of a relevant device places a device on the market under their own name, but does not have a registered place of business in a Member State, the manufacturer shall—
(a) designate a single authorised representative; and
(b) ensure that the authorised representative has a registered place of business in a Member State.
5 The authorised representative referred to in paragraph (4) shall provide the competent authority of the Member State in which they have their registered place of business with the information referred to in paragraph (3) above.”

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