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The Medical Devices Regulations 2002

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Changes over time for: Section 30

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Version Superseded: 30/04/2021

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Manufacturers etc. and conformity assessment procedures for active implantable medical devicesE+W+S

30.—(1) A manufacturer of a relevant device or, where applicable, [F1their UK responsible person] 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, [F2their UK responsible person] 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.

[F3(3) [F4The manufacturer of a relevant device, who places devices on the market, in accordance with the procedure referred to in Article 9(2) of Directive 90/385, or, if not the manufacturer, the person placing custom-made devices on the market under that Article, must 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.

F5(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F5(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

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E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Manufacturers etc. and conformity assessment procedures for active implantable medical devicesN.I.

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.

[F6(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 [F7a relevant state], the manufacturer shall—

(a)designate a single authorised representative; and

(b)ensure that the authorised representative has a registered place of business in [F7a relevant state].

(5) The authorised representative referred to in paragraph (4) shall provide the competent authority of [F8the relevant state] in which they have their registered place of business with the information referred to in paragraph (3) above.]

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F7Words in reg. 30(4) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 11(a)

F8Words in reg. 30(5) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 11(b)

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