Guidance

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

What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland.

Overview

This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to act as the Competent Authority for medical devices in Northern Ireland. For more information about placing a device on the Northern Ireland market from 1 January 2021, please read our guidance on regulating 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.

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 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, 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:

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) (PDF, 7.03MB, 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.

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)

The exemption for manufacturing or modifying and using medical devices or IVDs within the same health institution (also known as ‘in house manufacture’) 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.

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.

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.

Contact the MHRA

Please direct any queries on the new Regulations to

devices.regulatory@mhra.gov.uk

Published 29 August 2017
Last updated 29 April 2021 + show all updates
  1. Update to information under section 'Importer requirements'

  2. A new section on importer requirements has been added.

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

  4. 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.

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

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

  7. contact email address updated.

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

  9. First published.