UK Statutory Instrument SI 2023 United Kingdom

Medical Devices (Amendment) (Great Britain) Regulations 2023

These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. The 2002 Regulations were made under section 2(2) of the European Communities Act 1972 …

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
MHRA
Status
In Force

What it defines

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

10 other provisions — procedural and definitional
s.001 Citation, extent and application
s.002 Commencement
s.003 Amendments to the Medical Devices Regulations 2002
s.004 Amendments to regulation 1ZA (expiry of certain provisions in these Regulations)
s.005 Amendments to regulation 2 (interpretation)
s.006 Amendments to regulation 19B (obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42)
s.007 Amendments to regulation 19C (obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745)
s.008 Amendments to regulation 30A (obligations in Part III which are met by complying with obligations in Directive 90/385)
s.009 Amendments to regulation 44ZA (obligations in Part IV which are met by complying with obligations in Directive 98/79)
s.010 Amendments to regulation 44ZB (obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746)

Help complying

Guvnor’s practical routes through this instrument.

Placing a medical device on the GB market

End-to-end learning path for manufacturers bringing a medical device to the Great Britain market for the first time. Covers pre-market steps (classification, …

Medical device compliance quick check

Quick compliance verification for experienced medical device manufacturers. Check your device classification, registration status, marking validity, PMS system, and vigilance reporting readiness.

Selling medical devices in both GB and Northern Ireland

How to achieve dual-market access for medical devices across Great Britain and Northern Ireland. Covers the different regulatory frameworks, marking options, conformity …
1 more guide that reference this instrument
UKCA and CE marking for medical devices

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.