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.

Part 1 — Amendment of the 2002 Regulations

Browse 7 other sections in this Part — procedural / definitional / commencement

s.003

Amendment of Part 1 of the 2002 Regulations

s.004

Amendment of Part II of the 2002 Regulations

s.005

Amendment of Part III of the 2002 Regulations

s.006

Amendment of Part IV of the 2002 Regulations

s.007

Amendment of Part V of the 2002 Regulations

s.008

Amendment of Part VI of the 2002 Regulations

s.009

Amendment of Part VII of the 2002 Regulations

Part 2 — New Part VIII of the Medical Devices Regulations

Browse 1 other section in this Part — procedural / definitional / commencement

s.010

s.10

Part 3 — New part IX of the Medical Devices Regulations

Browse 1 other section in this Part — procedural / definitional / commencement

s.011

s.11

Part 4 — New Schedules to the 2002 Regulations

Browse 1 other section in this Part — procedural / definitional / commencement

s.012

s.12

Other sections — not classified into a Part

These sections exist in the Act but the contents-of-Parts walker did not place them under a Part. Likely amendments or sections inserted out of the original Part structure.

Browse 2 other unclassified sections

s.001

Citation, commencement and application

s.002

Interpretation

Official guidance

Authoritative sources published by regulators or government explaining this legislation.

UK Approved Bodies for medical devices (opens in a new tab) Publication
MHRA consultation on indefinite CE recognition (opens in a new tab) Detailed Guidance
Register medical devices to place on the market (opens in a new tab) Detailed Guidance
Medical devices - conformity assessment and the UKCA mark (opens in a new tab) Detailed Guidance
Regulating medical devices in the UK (MHRA guidance) (opens in a new tab) Detailed Guidance
Using the UKCA marking (opens in a new tab) Detailed Guidance

Enforcement and responsible bodies

The regulators that administer or enforce this legislation.

MHRA

Medicines and Healthcare products Regulatory Agency

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

Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

At a glance

Step-by-step journeys using this legislation

Export to the EU after Brexit

Run a healthcare business

Respond to a medicines or controlled drugs incident

Placing a medical device on the GB market

Medical device compliance quick check

Selling medical devices in both GB and Northern Ireland

Relevant guidance

Direct — cites this Act

UKCA and CE marking for medical devices

Supporting — topic alignment

Medical devices and equipment compliance

Medical devices: placing on the GB market

Mentioned in related content

What this Act requires

Part 1 — Amendment of the 2002 Regulations

Amendment of Part 1 of the 2002 Regulations

Amendment of Part II of the 2002 Regulations

Amendment of Part III of the 2002 Regulations

Amendment of Part IV of the 2002 Regulations

Amendment of Part V of the 2002 Regulations

Amendment of Part VI of the 2002 Regulations

Amendment of Part VII of the 2002 Regulations

Part 2 — New Part VIII of the Medical Devices Regulations

s.10

Part 3 — New part IX of the Medical Devices Regulations

s.11

Part 4 — New Schedules to the 2002 Regulations

s.12

Other sections — not classified into a Part

Citation, commencement and application

Interpretation

Official guidance

Enforcement and responsible bodies

MHRA

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Regulators