Placing a medical device on the GB market
- 1 step
UK Statutory Instrument
2021
Northern Ireland
The Market Surveillance (Northern Ireland) Regulations 2021
These Regulations extend to Northern Ireland only and are made under section 8C of the European Union (Withdrawal) Act 2018 (c. 16) to implement certain provisions of Regulation (EU) No 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products (“Regulation 2019/1020”).
At a glance
Enforced by
What's here
11 compliance obligations, 2 practical guides · 3 journeys
Penalty landscape
4 of 11 obligations carry an unlimited fine. 2 carry different penalties and 5 have no criminal penalty — flagged in the list below.
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Any Person 7
- Operator 1
Plus 3 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
Step-by-step journeys using this legislation
Walkthroughs that take you from a real business situation to compliance.
Medical device compliance quick check
- 1 step
Selling medical devices in both GB and Northern Ireland
- 2 steps
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Supporting — topic alignment
1 guidesMentioned in related content
1 guidesOther Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Any Person also bound by 2338 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 169 duties
- Merchant Shipping Act 1995 1995 144 duties
- Insolvency (England and Wales) Rules 2016 2016 101 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 95 duties
Operators also bound by 730 other Acts (top 5 shown)
- Regulation (EU) No 965/2012 (Air Operations) 2012 138 duties
- Commission Implementing Regulation (EU) 2018/2066 of 19 December 2018 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council and amending Commission Regulation (EU) No 601/2012 (Text with EEA relevance) 2018 121 duties
- Commission Regulation (EU) No 601/2012 of 21 June 2012 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council (Text with EEA relevance) (repealed) 2012 112 duties
- Space Industry Regulations 2021 2021 75 duties
- Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (Text with EEA relevance) 2016 66 duties
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.
Schedules
Power to seize and detain products
Other duties (1) — Crown / regulator
- MHRA officers may seize and detain non-compliant products with safeguards Statutory regulator
Power to seize documents required as evidence
Other duties (1) — Crown / regulator
- MHRA officers must follow seizure procedures when taking documents as evidence Statutory regulator
Offence of obstruction
Fine up to £1,000- Obstruct an enforcer or fail to provide required assistance or information Any Person
Offence of purporting to act as an officer
Unlimited fine- Pretend to be an enforcement officer Any Person
Procedure for notice under paragraph 2
Other duties (1) — Crown / regulator
- MHRA must issue information notices in writing, specifying purpose and function Statutory regulator
Modifications to the 1978 Order
Unlimited fine- Carry on activities despite a prohibition notice Any Person
Recall notice
- Comply with a product recall notice from the MHRA Operator
An ISSP must take the steps specified in an online...
- Comply with online interface notice from enforcer Any Person
Offences
Unlimited fine- Fail to comply with market surveillance rules for products Any Person
Penalties
Unlimited fine- Breach market surveillance requirements Any Person
Liability of persons other than the principal offender
- Cause another person to commit a market surveillance offence Any Person
Browse 39 other Schedules — structural / supplementary
Interpretation of terms used in this Schedule
Power to inspect products etc
Power to test equipment
Power to require the production of documents
Power to decommission or switch off fixed installations
Power to decommission or switch off any medical device
Power to break open container etc
Power to enter premises with warrant
Entry to premises under warrant
Power to require the production of information
Power to require assistance from person on premises
Access to seized products and documents
Notice of testing of products
Appeals against detention of products and documents
Compensation
Powers of a district council
Civil proceedings
Criminal proceedings
Enforcement of notice under paragraph 2
Limitations on use of information provided in response to a notice under paragraph 2
Power to purchase products
Power to observe carrying on of a business etc
Power to enter premises without a warrant
Application of paragraphs 10 to 17
Enforcement powers under the 1987 Act
Modifications to the 1987 Act
HSAW enforcer
Enforcement powers under the 1978 Order
Compliance Notice
Withdrawal Notice
Appeals against notices
Appropriate court for appeals against notices etc and further appeals
Online interface notice
This paragraph applies where the enforcer considers that service of...
An online interface notice must specify only such steps as...
The duty imposed by paragraph (4) is enforceable only—
For the purposes of this Schedule, “ISSP” means an information...
Defence of due diligence
Time limit for prosecution of offences
Browse 9 other sections — procedural / definitional / commencement
Citation, commencement and extent
Interpretation
Application
Designation of market surveillance authorities
Enforcement powers giving effect to Article 14(4) of the MSC Regulation
Enforcer's legislation
Table of enforcer's legislation
Offences
Amendment of Schedule 5 to the Consumer Rights Act 2015
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.
Explore more
Browse legislation
Find other UK business legislation with related guidance.
Regulators
Learn more about the bodies that enforce this legislation.