- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
PART 2 Amendment of the Medical Devices Regulations 2002
4.Amendment of regulation 2 in relation to England, Scotland and Wales (interpretation)
5.Amendment of regulation 16 in relation to England, Scotland and Wales (procedures for general medical devices for clinical investigations)
6.Amendment of regulation 29 in relation to England, Scotland and Wales (procedures for active implantable medical devices for clinical investigations)
8.Amendment of regulation 53 in relation to England, Scotland and Wales (fees in connection with the registration of devices and changes to registration details)
9.Amendment of regulation 53 in relation to Northern Ireland (fees in connection with the registration of devices and changes to registration details)
10.Amendment of regulation 54 in relation to England, Scotland and Wales (fees payable in connection with the designation of approved bodies)
11.Amendment of regulation 55 in relation to England, Scotland and Wales (fees payable in connection with the designation etc. of conformity assessment bodies)
12.Amendment of regulation 55 in relation to Northern Ireland (fees payable in connection with the designation etc. of conformity assessment bodies)
13.Amendment of regulation 56 in relation to England, Scotland and Wales (fees payable in relation to clinical investigation notices)
Part 3 Amendment of the Blood Safety and Quality Regulations 2005
Part 4 Amendment of the Medical Devices (Northern Ireland Protocol) Regulations 2021
18.Amendment of the Medical Devices (Northern Ireland Protocol) Regulations 2021
19.Amendment of regulation 7 (registration of custom-made devices)
21.New regulation 17A (advice in relation to intended clinical investigations)
22.Amendment of regulation 19 (fees payable in connection with the designation of notified bodies)
24.Amendment of Schedule 1 (fees for clinical investigations)
25.Amendment of Schedule 2 (fees in connection with the designation of notified bodies)
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.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the 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:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
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: