- Draft legislation
This is a draft item of legislation. This draft has since been made as a UK Statutory Instrument: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 No. 910
3.In regulation 2 after the definition of “clinical data”, insert—...
4.In regulation 33(1) after “in vitro diagnostic medical devices”, insert...
5.After regulation 34, insert— Approval requirement for coronavirus test devices...
6.After regulation 38, insert— Applications for approval of coronavirus test...
7.In regulation 39 in the heading, for “regulations 34, 36...
8.After regulation 39, insert— Exemptions for coronavirus test devices (1) Regulation 34A does not apply where, in circumstances which...
9.After regulation 56 (fees payable in relation to clinical investigation...
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Draft Explanatory Memorandum sets out a brief statement of the purpose of a Draft Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Draft Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: