UK Statutory Instrument SI 2021/858 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 …

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Enforced by
MHRA
Status
Amended (in force with amendments)
Penalty ceiling
Prosecution 4 of 11 obligations carry an unlimited fine. 2 carry different penalties and 5 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person7 Operator1

Plus 3 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Any Person — also bound by 2340 other Acts
Operator — also bound by 746 other Acts

What it requires

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.

9 other provisions — procedural and definitional
s.001 Citation, commencement and extent
s.002 Interpretation
s.003 Application
s.004 Designation of market surveillance authorities
s.005 Enforcement powers giving effect to Article 14(4) of the MSC Regulation
s.006 Enforcer's legislation
s.007 Table of enforcer's legislation
s.008 Offences
s.009 Amendment of Schedule 5 to the Consumer Rights Act 2015
Schedules

Schedules

11 of 50 shown
s.sch001 Power to seize and detain products Regulated
Other duties (1) — Crown / regulator
  • MHRA officers may seize and detain non-compliant products with safeguardsStatutory regulator
s.sch001 Power to seize documents required as evidence Regulated
Other duties (1) — Crown / regulator
  • MHRA officers must follow seizure procedures when taking documents as evidenceStatutory regulator
s.sch001 Offence of obstruction Prosecution
  • Obstruct an enforcer or fail to provide required assistance or informationAny Person

Fine up to £1,000

s.sch001 Offence of purporting to act as an officer Prosecution
  • Pretend to be an enforcement officerAny Person

Unlimited fine

s.sch001 Procedure for notice under paragraph 2 Regulated
Other duties (1) — Crown / regulator
  • MHRA must issue information notices in writing, specifying purpose and functionStatutory regulator
s.sch003 Modifications to the 1978 Order Prosecution
  • Carry on activities despite a prohibition noticeAny Person

Unlimited fine

s.sch004 Recall notice Regulated
  • Comply with a product recall notice from the MHRAOperator
s.sch005 An ISSP must take the steps specified in an online... Regulated
  • Comply with online interface notice from enforcerAny Person
s.sch006 Offences Prosecution
  • Fail to comply with market surveillance rules for productsAny Person

Unlimited fine

s.sch006 Penalties Prosecution
  • Breach market surveillance requirementsAny Person

Unlimited fine

s.sch006 Liability of persons other than the principal offender Regulated
  • Cause another person to commit a market surveillance offenceAny Person
39 other schedules
s.sch001 Interpretation of terms used in this Schedule
s.sch001 Power to inspect products etc
s.sch001 Power to test equipment
s.sch001 Power to require the production of documents
s.sch001 Power to decommission or switch off fixed installations
s.sch001 Power to decommission or switch off any medical device
s.sch001 Power to break open container etc
s.sch001 Power to enter premises with warrant
s.sch001 Entry to premises under warrant
s.sch001 Power to require the production of information
s.sch001 Power to require assistance from person on premises
s.sch001 Access to seized products and documents
s.sch001 Notice of testing of products
s.sch001 Appeals against detention of products and documents
s.sch001 Compensation
s.sch001 Powers of a district council
s.sch001 Civil proceedings
s.sch001 Criminal proceedings
s.sch001 Enforcement of notice under paragraph 2
s.sch001 Limitations on use of information provided in response to a notice under paragraph 2
s.sch001 Power to purchase products
s.sch001 Power to observe carrying on of a business etc
s.sch001 Power to enter premises without a warrant
s.sch001 Application of paragraphs 10 to 17
s.sch002 Enforcement powers under the 1987 Act
s.sch002 Modifications to the 1987 Act
s.sch003 HSAW enforcer
s.sch003 Enforcement powers under the 1978 Order
s.sch004 Compliance Notice
s.sch004 Withdrawal Notice
s.sch004 Appeals against notices
s.sch004 Appropriate court for appeals against notices etc and further appeals
s.sch005 Online interface notice
s.sch005 This paragraph applies where the enforcer considers that service of...
s.sch005 An online interface notice must specify only such steps as...
s.sch005 The duty imposed by paragraph (4) is enforceable only—
s.sch005 For the purposes of this Schedule, “ISSP” means an information...
s.sch006 Defence of due diligence
s.sch006 Time limit for prosecution of offences

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 …
2 more guides that reference this instrument
Placing medical devices on the Northern Ireland market 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.