UK Statutory Instrument 2023 United Kingdom

Medical Devices (Amendment) (Great Britain) Regulations 2023

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Enforced by

MHRA

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1 practical guide · 3 journeys

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Relevant guidance

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Supporting — topic alignment

1 guides

What this Act requires

Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.

Browse 10 other sections — procedural / definitional / commencement
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)

Official guidance

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Enforcement and responsible bodies

The regulators that administer or enforce this legislation.

Medicines and Healthcare products Regulatory Agency

Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.

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