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Guidance
Medical devices: EU regulations for MDR
and IVDR (Northern Ireland)

Information about the new EU Regulations for medical

devices (MDR) and in vitro diagnostic medical devices
(IVDR), and their implementation in Northern Ireland

From: Medicines and Healthcare products Regulatory Agency

(/government/organisations/medicines-and-healthcare-products-regulatory-
agency)
Published 29 August 2017
Last updated 21 September 2023 —

Contents
Related content
 — Overview Medical devices: software
applications (apps)
— The legislation (/government/publications/medical-
— The application of the MDR and IVDR in Northern Ireland devices-software-applications-apps)
— How to comply with the legal requirements In vitro diagnostic medical devices:
— Introductory guide to MDR and IVDR guidance on legislation
— Health Institutions in Northern Ireland (/government/publications/in-vitro-
diagnostic-medical-devices-guidance-
— Importer requirements on-legislation)
— Medical devices: clinical investigations and performance studies in
Northern Ireland Medical devices: conformity
assessment and the UKCA mark
(/guidance/medical-devices-conformity-
assessment-and-the-ukca-mark)
Overview
Regulatory guidance for medical
This guidance provides information on the EU Regulations for medical devices
devices (MDR) and in vitro diagnostic medical devices (IVDR). (/government/collections/regulatory-
guidance-for-medical-devices)
From 1 January 2021 the Medicines and Healthcare products Regulatory
Agency (MHRA) will continue to act as the Competent Authority for medical Borderlines with medical devices
devices in Northern Ireland. For more information about placing a device on
the Northern Ireland market from 1 January 2021, please read our guidance and other products in Great Britain
on regulating medical devices (https://www.gov.uk/guidance/regulating-medical- (/government/publications/borderlines-
devices-in-the-uk#NI). with-medical-devices)

This guidance is only relevant for medical devices on the Northern Ireland
market. For information on the regulation of medical devices on the Great
Britain (England, Wales and Scotland) market, please see our published
guidance (https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk).
The legislation
Currently, devices are regulated under:

Directive 93/42/EEC on medical devices (EU MDD)

Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

These directives are given effect in UK law through the Medical Devices
Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Schedule 1 of the Medical Devices (Amendment etc.) (EU Exit) Regulations
2020 (https://www.legislation.gov.uk/uksi/2020/1478/contents/made) sets out the
specific requirements for Northern Ireland.

The application of the MDR and IVDR in Northern

Ireland
The Medical Device Regulations (2017/745) (MDR) and the in vitro
Diagnostic Medical Device Regulations (2017/746) (IVDR) will fully apply in
EU Member States from 26 May 2021 and 26 May 2022 respectively.

Under the terms of the Northern Ireland Protocol

(https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attach
ment_data/file/840230/Revised_Protocol_to_the_Withdrawal_Agreement.pdf), from
1 January 2021, the rules for placing medical devices on the Northern
Ireland market will differ from those applicable to Great Britain (England,
Wales and Scotland).

The MDR will apply in Northern Ireland from 26 May 2021, and the IVDR will
apply in Northern Ireland from 26 May 2022, in line with the EU’s
implementation timeline.
We recommend you familiarise yourself with the legislation that is applicable
to your devices:

General medical devices: The Regulation on Medical Devices 2017/745

(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-
20200424)
In vitro diagnostic medical devices (IVDs): The Regulation on In Vitro
Diagnostic Medical Devices 2017/746 (https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A02017R0746-20170505)

How to comply with the legal requirements

If you are manufacturing or supplying a medical device, you must meet new
obligations set out in the Regulations, including, but not limited to, ensuring
that:

the device has been correctly classified against the new risk classification
criteria (Annex VIII of the MDR and IVDR)
general safety and performance requirements are met, including for
labelling, and technical documentation and quality management systems
(Annex I of the MDR and IVDR)
increased requirements for clinical evidence are met (Annex XIV of the
MDR and IVDR)
manufacturers have a person responsible for regulatory compliance in
place (Article 15 of the MDR and IVDR)
as an importer you meet the requirements set out in Article 13 of the MDR
and IVDR
as a distributor you meet the requirements set out in Article 14 of the
MDR and IVDR
Introductory guide to MDR and IVDR
We have created an interactive guide to the new EU Regulations for
medical devices (MDR) and in vitro diagnostic medical devices (IVDR)
(https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attach
ment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf) (PDF, 7.03 MB, 27
pages)

Please note that since publication of the above guide the implementation
timeline of the MDR has been delayed and will now fully apply from 26 May
2021 in Northern Ireland.

Conformity Assessment marking

For medical devices and IVDs, CE marking will continue to be used and
recognised for the Northern Ireland market, and manufacturers based in
Northern Ireland will not require an authorised representative established in
the EU. For the purposes of the CE mark, an EU-recognised Notified Body,
where required, must be used.

Where a UK Notified Body has been used for your conformity assessment,
you must place a CE UKNI mark on the device. Goods bearing the CE UKNI
marking will not be accepted on the EU market. Further guidance on
applying the UKNI marking (https://www.gov.uk/guidance/regulating-medical-
devices-in-the-uk#NI).

Class I manufacturers can continue to self-declare their conformity against

the MDR from 26 May 2021.

Health Institutions in Northern Ireland

Guidance on the health institution exemption (HIE) – IVDR and MDR
(Northern Ireland) (https://www.gov.uk/government/publications/mhra-guidance-on-
the-health-institution-exemption-hie-ivdr-and-mdr-northern-ireland)

The exemption for manufacturing or modifying and using medical devices or

IVDs within the same health institution (also known as ‘in house
manufacture’ (https://www.gov.uk/government/publications/in-house-manufacture-
of-medical-devices/in-house-manufacture-of-medical-devices)) will continue to
apply. However, additional requirements for these devices must be met.

Health institutions wishing to apply the exemption under the new

Regulations will need to ensure that:

products meet the relevant General Safety and Performance

Requirements (Annex I of the MDR and IVDR)
there is an appropriate quality system in place
there is a justification for applying the exemption
technical documentation is in place

The full requirements of implementing the healthcare institution exemption

can be found in Article 5(5) of the MDR and IVDR.

The MHRA has published guidance on implementing the Health Institution

Exemption in Northern Ireland. Please see our detailed guidance document
for health institutions in Northern Ireland wishing to apply the exemption to
their medical devices or IVDs.

Importer requirements

Definition of an importer
The MDR and IVDR define an ‘importer’ as “any natural or legal person
established within the Union that places a device from a third country on the
Union market”.

You’ll become an importer if you’re the one bringing goods for the first time
into Northern Ireland (or the EU) from either Great Britain or another non-EU
country and placing them on the Northern Ireland (or the EU) market.

An importer can be an individual or a company, such as a retailer, retail

outlet or wholesaler, who is placing the device on the market. There may be
cases where the end customer, such as a hospital or dentist, might be
considered to be the importer. The importer can be located in Northern
Ireland, the Republic of Ireland or another EU Member State.

For more information, please also see our guidance for retailers supplying
devices into Northern Ireland (https://www.gov.uk/guidance/guidance-for-retailers-
supplying-medical-devices-to-northern-ireland).

Legal obligations

If you are an importer, you will need to make sure:

the device has been CE marked or, for devices for the Northern Ireland
market only, also has a UKNI indication
that the EU declaration of conformity of the device has been drawn up
a manufacturer is identified and that, where relevant, an authorised
representative has been designated by the manufacturer
the device is labelled in accordance with MDR and accompanied by the
required instructions for use
where applicable, a UDI has been assigned by the manufacturer
 the device has been registered in Eudamed, once Eudamed is fully
functional
you comply with the manufacturer’s transport and storage requirements
you keep a register of complaints, of non-conforming devices and of
recalls and withdrawals, and provide the manufacturer, authorised
representative and distributors with any information requested by them
you inform the manufacturer and their authorised representative if you
have reason to believe a device does not conform to the requirements
you keep a copy of the EU declaration of conformity and relevant
certificates for 10 years (and 15 years for implantable devices)
you cooperate with the MHRA and provide samples or grant access to the
devices

Full importer obligations can be found in Article 13 of the MDR and IVDR.

Labelling requirements

Importers will also need to provide the following details along with the
device:

name, registered trade name or registered trademark

your place of business
the address at which you can be contacted

These details can appear on the packaging, instructions for use or in a

document accompanying the device, such as an invoice.

Registration requirements
In cases where the Northern Ireland importer is not the Northern Ireland-
based Authorised Representative or the UK Responsible Person, the
importer is required to inform the relevant Northern Ireland-based
Authorised Representative or UK Responsible Person of their intention to
import a device. In such cases, the Northern Ireland-based Authorised
Representative or UK Responsible Person is required to provide the MHRA
with a list of device importers.

This notification only needs to happen once, and not for every batch of
device imported.

The requirements for this apply in line with the registration grace periods set
out in our guidance (https://www.gov.uk/guidance/register-medical-devices-to-
place-on-the-market).

If you have already registered your device with the MHRA for the purposes
of Great Britain (England, Wales and Scotland), it will not need to undergo
any further registration in Northern Ireland by the importer, so long as you
have indicated that the device is also for the Northern Ireland market. Such
devices must meet the regulatory requirements for the Northern Ireland
market.

Medical devices: clinical investigations and

performance studies in Northern Ireland
Information about changes to the operation of certain clinical investigations
and performance studies in Northern Ireland.

Certain clinical investigations and performance studies that take place in

Northern Ireland require the sponsors to be established either in Northern
Ireland or the EU or to have a legal representative established in Northern
Ireland or the EU.
The rules that apply (Medical Device Regulation (Regulation 2017/745)
(MDR) and In Vitro Diagnostics Regulation (Regulation 2017/746) (IVDR)
allow the UK to disapply these rules.

This requirement applies if the investigation or study is only taking place

within its territory and not in the EU. Therefore, the MHRA is disapplying the
requirement for the sponsor or their legal representative of a clinical
investigation or performance study to be established in Northern Ireland or
the EU, provided all of the following conditions are met:

The investigation or study must also be taking place in both Northern

Ireland and Great Britain.
The investigation or study must not be taking place in an EU Member
State.
The sponsor must be either established in or have a written agreement
with a legal representative in Great Britain, who is responsible for
ensuring compliance with the sponsor’s obligations in the MDR or IVDR.
The sponsor must establish a contact person in Northern Ireland for the
clinical investigation or performance study, who will be the addressee for
all communications with the sponsor provided for in MDR or IVDR. Any
communication with that contact person is deemed to be communication
with the sponsor.

All remaining requirements under the MDR and IVDR apply. This guidance
will take immediate effect.

For further information, please contact the MHRA on

MHRACustomerServices@mhra.gov.uk.
Published 29 August 2017
Last updated 21 September 2023 - hide all updates

21 September 2023
Updated to include Medical devices: Clinical investigations and performance studies in
Northern Ireland replacing Temporary Disapplication of Sponsors and Legal Representatives
in Northern Ireland.

20 September 2023

Information on Temporary Disapplication of Sponsors and Legal Representatives in

Northern Ireland added.

29 April 2021

Update to information under section 'Importer requirements'

5 March 2021

A new section on importer requirements has been added.

31 December 2020

This page has been updated due to the end of the Brexit transition period.

24 April 2020

Published a new section following European Parliament and Council decision to delay the
full implementation of the Medical Device Regulation by one year to 26 May 2021.

12 October 2018

Added new section on Guidance for Annex XVI manufacturers and added PDF attachment.

5 February 2018

Added a link to our consultation on the Health institution exemption for IVDR/MDR

18 December 2017
contact email address updated.

11 September 2017

Added a one-page guide to outline to key changes in the new MDR IVDR which affect health
institutions.

29 August 2017

First published.

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