UK Statutory Instrument 2021 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 (OJ L 117, 5.5.2017) (“Regulation (EU) 2017/745”). Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement between the United Kingdom and the European Union (“the Protocol”) provides that the EU law listed in Annex 2 to the Protocol will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/745 is listed in Annex 2 and applied from 26 May 2021. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/745 in domestic law. Show full description
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At a glance

Enforced by

MHRA

What's here

12 compliance obligations, 2 practical guides · 3 journeys

Who this Act binds

Business-side actors with duties under this Act, ranked by how often they appear.

  • Any Person 5
  • Manufacturer 5

Plus 2 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.

Relevant guidance

Practical guides for businesses affected by this Act, ordered by how closely they engage with it.

Supporting — topic alignment

1 guides

Mentioned in related content

1 guides

Other 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)
Manufacturers also bound by 472 other Acts (top 5 shown)

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.

s.007

Registration of custom-made devices

  • Register custom-made medical devices with the MHRA within 28 days Manufacturer
s.010

UK(NI) indication under Regulation (EU) 2017/745

  • Affix UK(NI) indication to CE-marked medical devices Manufacturer
s.010

UK(NI) indication under Regulation (EU) 2017/746

  • You must affix UK(NI) indication alongside CE mark on applicable medical devices Manufacturer
s.011

Ethical review of clinical investigations

  • Get ethical review and submit opinion before starting clinical investigation Any Person
s.012

Prior authorisation of clinical investigations by the Secretary of State

Other duties (1) — Crown / regulator
  • Secretary of State must notify clinical investigation sponsor of authorisation decision within set timeframes Crown / Minister / Government department
s.013

Arbitration following the refusal of a clinical investigation application

Other duties (1) — Crown / regulator
  • Secretary of State must decide on clinical investigation after arbitration report Crown / Minister / Government department
s.016

Clinical investigation fees

  • Pay the relevant fee for clinical investigation applications and modifications Any Person
s.017

Ethical review of performance studies

  • Submit ethics committee opinion before starting a performance study Manufacturer
s.017

Arbitration following the refusal of a performance study application

  • Pay arbitration fees if you challenge a refused study application Any Person
s.017

Damage compensation in relation to performance studies

  • Hold sufficient insurance or financial resources for performance study liability Manufacturer
s.018

Notified bodies

  • Provide documents requested by Secretary of State when designation is restricted, suspended, or withdrawn Any Person
s.reg.a11

Legal representatives and contact persons for clinical investigations

  • Appoint a contact person in Northern Ireland for clinical investigations Any Person
Browse 46 other sections — procedural / definitional / commencement
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.008

Certificates of free sale under Regulation (EU) 2017/745 - fee

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

Read the full Act on legislation.gov.uk (opens in a new tab)

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.

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Regulators

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