UK Statutory Instrument SI 2021/905 United Kingdom

The Medical Devices (Northern Ireland Protocol) Regulations 2021

These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC …

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

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer6 Any Person4 Conformity Assessment Body1

Plus 2 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.

Manufacturer — also bound by 502 other Acts
Any Person — also bound by 2340 other Acts
Conformity Assessment Body — also bound by 47 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.

s.007 Registration of custom-made devices Regulated
  • Register custom-made medical devices with the MHRA within 28 daysManufacturer
s.008 Certificates of free sale under Regulation (EU) 2017/745 - fee Regulated
  • Pay £75 fee for certificate of free saleManufacturer
s.010 UK(NI) indication under Regulation (EU) 2017/745 Regulated
  • Affix UK(NI) indication to CE-marked medical devicesManufacturer
s.010 UK(NI) indication under Regulation (EU) 2017/746 Regulated
  • You must affix UK(NI) indication alongside CE mark on applicable medical devicesManufacturer
s.011 Ethical review of clinical investigations Regulated
  • Get ethical review and submit opinion before starting clinical investigationAny Person
s.012 Prior authorisation of clinical investigations by the Secretary of State Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must notify clinical investigation sponsor of authorisation decision within set timeframesCrown / Minister / Government department
s.013 Arbitration following the refusal of a clinical investigation application Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must decide on clinical investigation after arbitration reportCrown / Minister / Government department
s.016 Clinical investigation fees Regulated
  • Pay the relevant fee for clinical investigation applications and modificationsAny Person
s.017 Ethical review of performance studies Regulated
  • Submit ethics committee opinion before starting a performance studyManufacturer
s.017 Arbitration following the refusal of a performance study application Regulated
  • Pay arbitration fees if you challenge a refused study applicationAny Person
s.017 Damage compensation in relation to performance studies Regulated
  • Hold sufficient insurance or financial resources for performance study liabilityManufacturer
s.018 Notified bodies Regulated
  • Provide documents requested by Secretary of State when designation is restricted, suspended, or withdrawnConformity Assessment Body
s.reg.a11 Legal representatives and contact persons for clinical investigations Regulated
  • Appoint a contact person in Northern Ireland for clinical investigationsAny Person
45 other provisions — procedural and definitional
sch. 2 sch. 2
s.001 Citation and commencement
s.002 Extent and application
s.003 Interpretation
s.004 Scope
s.005 Reprocessing of single-use devices
s.006 Requirement on health institutions to provide information relating to implanted devices
s.009 Retention of documentation relating to conformity assessments and custom-made devices
s.010 Certificates of free sale under Regulation (EU) 2017/746 – fee
s.010 Retention of documentation relating to conformity assessments
s.014 Damage compensation in relation to clinical investigations
s.015 Retention of documentation relating to clinical investigations
s.017 Clinical investigations not carried out for a purpose specified in Article 62(1)
s.017 Advice in relation to intended clinical investigations
s.017 Legal representatives and contact persons for performance studies
s.017 Retention of documentation relating to performance studies
s.019 Fees payable in connection with the designation of notified bodies
s.019 Interpretation of Part 4A
s.019 Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
s.019 Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
s.019 Fees for pre-consultation meetings
s.020 Language requirements
s.021 Unpaid fees
s.022 Waivers, reductions and refunds
s.023 Offence of breaching certain provisions
s.024 Defence of due diligence
s.025 Offences by bodies corporate
s.026 Enforcement
s.027 Investigatory powers under the Consumer Rights Act 2015
s.028 Amendment of the Medicines and Medical Devices Act 2021
s.029 Amendments to the Medical Devices Regulations 2002
s.030 Amendment of regulation 2 (interpretation)
s.031 Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods)
s.032 Revocation and transitional provision
s.033 Amendment of regulation 10A (UK(NI) indication: general medical devices)
s.034 Amendment of regulation 19 (registration of persons placing general medical devices on the market)
s.035 Amendment of regulation 21B (registration of persons placing active implantable medical devices on the market)
s.036 Amendment of regulation 24A (UK(NI) indication: active implantable medical devices)
s.037 Amendment of regulation 36A (UK(NI) indication: in vitro diagnostic medical devices)
s.038 Amendment of the Blood Safety and Quality Regulations 2005
s.039 Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007
s.040 Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 2007
s.041 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
s.042 Amendment of the Economic Growth (Regulatory Functions) Order 2017
s.043 Amendment of the Market Surveillance (Northern Ireland) Regulations 2021

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.