Interpretation of Part VII
In this Part ...— “registrable device” means a device in respect of which, in accordance with the Medical Devices Directives, registration is required with the competent authorities of a Member State or (where appropriate) a State which is a Party to an Association Agreement; “relevant device” means a device that is a “relevant device” for the purposes of Part II, III or IV ....
Status of UK responsible person
(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (3) A UK responsible person— (a) may be proceeded against as a person placing the device on the market for the purposes of these regulations; (b) in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market. (4) If a person claims or purports to act as a UK responsible person , the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient evidence that he is a UK responsible person .
Enforcement etc.
(1A) It is the duty of the Secretary of State to enforce these regulations in relation to relevant devices and devices for performance evaluation. (1B) It is the duty of each weights and measures authority in Great Britain and each district council in Northern Ireland to enforce these regulations within its area (concurrently with the Secretary of State) in relation to relevant devices that are ordinarily intended for private use or consumption. (1C) Nothing in this regulation authorises a weights and measures authority to bring proceedings in Scotland for an offence.
Compliance notices
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Restriction notices
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Notification of decisions etc.
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Centralised systems of records etc.
The Secretary of State shall perform, as respects Northern Ireland , the functions of the Member State under article 8 of Directive 90/385, article 10 of Directive 93/42 and article 11(1) to (3) of Directive 98/79.
Revocations
The following provisions are hereby revoked— (a) the Active Implantable Medical Devices Regulations 1992 ; (b) the Medical Devices Regulations 1994 ; (c) the Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 ; (d) the Medical Devices Fees Regulations 1995 ; (e) the Medical Devices Fees (Amendment) Regulations 1997 ; (f) the In Vitro Diagnostic Medical Devices Regulations 2000 ; and (g) regulations 6 and 13 of the Medicines (Codification Amendments Etc.) Regulations 2002 .
Review
Before the end of 31st December 2025 , the Secretary of State must— (a) carry out a review of these Regulations; (b) set out the conclusions of the review in a report; and (c) publish the report.
Provisions on this page are reproduced verbatim from official open data. See the attribution line.
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