UK Statutory Instrument SI 2019 United Kingdom

Medical Devices (Amendment ) (EU Exit) Regulations 2019

These Regulations are made in exercise of the powers conferred by section 8(1) of , paragraph 7(2) of Schedule 4 and paragraph 21 of Schedule 7 to the European Union (Withdrawal) Act 2018 (c. 16) (“the Withdrawal Act”) in order to address failures of retained EU law to operate effectively …

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
MHRA
Status
Amended (in force with amendments)

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.

Part 1

Amendment of the 2002 Regulations

0 of 7 sections shown
7 other sections in this Part — procedural and definitional
s.003 Amendment of Part 1 of the 2002 Regulations (opens in a new tab)
s.004 Amendment of Part II of the 2002 Regulations (opens in a new tab)
s.005 Amendment of Part III of the 2002 Regulations (opens in a new tab)
s.006 Amendment of Part IV of the 2002 Regulations (opens in a new tab)
s.007 Amendment of Part V of the 2002 Regulations (opens in a new tab)
s.008 Amendment of Part VI of the 2002 Regulations (opens in a new tab)
s.009 Amendment of Part VII of the 2002 Regulations (opens in a new tab)
Part 2

New Part VIII of the Medical Devices Regulations

0 of 1 section shown
1 other section in this Part — procedural and definitional
s.010 After regulation 67 of the 2002 Regulations insert— PART VIII... (opens in a new tab)
Part 3

New part IX of the Medical Devices Regulations

0 of 1 section shown
1 other section in this Part — procedural and definitional
s.011 After regulation 135 (as inserted by regulation 10) insert— PART IX... (opens in a new tab)
Part 4

New Schedules to the 2002 Regulations

0 of 1 section shown
1 other section in this Part — procedural and definitional
s.012 After Schedule 2 to the 2002 Regulations insert— SCHEDULE 2A... (opens in a new tab)
2 other provisions
s.001 Citation, commencement and application (opens in a new tab)
s.002 Interpretation (opens in a new tab)

Help complying

Guvnor’s practical routes through this instrument.

Export to the EU after Brexit

Navigate post-Brexit changes for EU exports - customs declarations, rules of origin, VAT, and product labelling

Run a healthcare business

Ongoing compliance for CQC-registered healthcare providers covering inspections, professional registration, safeguarding, clinical governance, medicines management, and staff obligations

Respond to a medicines or controlled drugs incident

What to do when a medicines incident occurs: medication error, controlled drug discrepancy, or CD theft/loss. Covers securing the patient and evidence, …

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 …

UKCA and CE marking for medical devices

How to choose between UKCA and CE marking for your medical device on the GB market. Covers UKCA marking via UK Approved …
5 more guides that reference this instrument
Medical devices and equipment compliance Medical devices: placing on the GB market MHRA authorisation for medicines and medical devices MHRA licensing for medicines and medical devices Placing medical devices on the Northern Ireland market

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