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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART III
- Regulation 30
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Manufacturers etc. and conformity assessment procedures for active implantable medical devicesU.K.
30.—(1) A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 90/385 shall observe the manufacturer’s obligations set out in that procedure that apply to him.
(2) A manufacturer of a relevant device or, where applicable, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 90/385 at an intermediate stage of manufacture of the device.
[F1(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.]
Textual Amendments
F1Reg. 30(3)-(5) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 14
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