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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART IV
- Regulation 34C
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The Medical Devices Regulations 2002, Section 34C is up to date with all changes known to be in force on or before 05 November 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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[F1Transitional provisions for coronavirus test devicesU.K.
34C.—(1) The requirements in regulation 34A do not apply in respect of any period before 1st September 2021.
(2) A person may place on the market, put into service or supply a coronavirus test device from 1st September 2021 until the end of 31st October 2021 if—
(a)that person has made an application to the Secretary of State in respect of that device, in accordance with regulation 38A; or
(b)that person is not—
(i)the manufacturer of the device,
(ii)a person acting as the manufacturer’s UK responsible person appointed for the purposes of regulation 33A or under regulation 44A, or
(iii)a person acting as the manufacturer’s authorised representative in Northern Ireland in accordance with regulation 44.]
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