UK Med Dev Guidance: Navigating UK and Northern Ireland Medical Device Regulations: Registration, Market Access, and Post-Brexit Dynamics

Sharan Murugan
10 hours ago
3 min read

In the transforming regulatory landscape for medical devices and in vitro diagnostics (IVDs), understanding the requirements for registration and market entry across the UK—especially in Great Britain (GB) and Northern Ireland (NI)—is essential for manufacturers, authorised representatives, and regulatory professionals.

Post-Brexit regulatory divergence has resulted in distinct registration and conformity requirements in Great Britain versus Northern Ireland.

Guidance: Registering Medical Devices to Place on the Great Britain Market

The first step for any manufacturer wishing to sell a medical device or IVD in Great Britain (England, Scotland, Wales) is to register the device with the Medicines and Healthcare products Regulatory Agency (MHRA) before placing it on the market.

Registration is mandatory for all device types, including custom-made devices and systems/procedure packs. Without registration, a device cannot legally be placed on the GB market.

Who Must Register?

Manufacturers wishing to place devices on the GB market must ensure each device is registered with MHRA. This applies regardless of:

Whether the manufacturer is based inside or outside the UK
Whether the device is a medical device or an IVD
Whether the device is low risk or high risk

Since 1 January 2021, non-UK manufacturers must also appoint a UK Responsible Person to take legal responsibility for registering the device in Great Britain.

What to Register and When

Before placing a device on the GB market, manufacturers must register:

The medical device itself
Its intended use, classification, and key details
The legal manufacturer’s name and UK Responsible Person’s details

For custom-made devices, registration remains mandatory, even though these devices are designed for a specific patient. › Custom-made devices previously compliant under EU directives can be registered under UK regulations for the GB market.

Failure to register means the device cannot be lawfully marketed in Great Britain, and enforcement action could follow.

What Registration Means

Once registered with MHRA, the device is recorded in the UK’s regulatory database. This registration is separate from a conformity assessment or market authorisation process. It simply means the device is listed with the UK regulator and can be legally placed on the market, provided it also satisfies other regulatory requirements like conformity assessment and UKCA marking (where applicable)

Guidance: Regulation of Medical Devices in Northern Ireland

Northern Ireland occupies a unique regulatory position under the Northern Ireland Protocol. While it is part of the UK, NI continues to align with European Union (EU) medical device legislation, meaning the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746) apply there.

How EU MDR and IVDR Apply in Northern Ireland

Under the terms of the Windsor Framework and the Northern Ireland Protocol:

EU MDR has applied in NI since 26 May 2021
EU IVDR has applied in NI since 26 May 2022

This means that, in addition to registering devices with the MHRA, manufacturers must also comply with EU-aligned rules for placing devices on the NI market.

CE Marking versus UKCA Marking

In Great Britain, medical devices are subject to UK Medical Devices Regulations 2002 (UK MDR 2002) and typically require a UKCA (UK Conformity Assessed) mark to show conformity. CE marking is no longer recognised for GB market access.

In contrast, in Northern Ireland, devices must carry a CE mark (or CE mark with UKNI indication if applicable) to comply with EU MDR/IVDR requirements when placed on the NI market. Because the NI market remains aligned with EU rules, the UKCA mark is not sufficient on its own for NI market access.

Where conformity assessment by a third party is required under EU MDR/IVDR, manufacturers should use an EU-recognised notified body for their conformity assessment in NI. This ensures the CE mark is valid for NI and EU markets.

Registration Requirements in Northern Ireland

Certain devices—including IVDs, custom-made devices, procedure packs, and systems—placed on the NI market must also be registered with the MHRA. Registration must be done within 28 days of the device being made available.

Exceptions exist for:

Class I medical devices
General IVDs (that are not for self-testing)

Provided the manufacturer is based in the EU/EEA or outside but with an EU-based Authorised Representative.

Authorised Representatives and Market Entry

Great Britain-based manufacturers must appoint an EU or Northern Ireland-based authorised representative to place devices on the NI market. If a Northern Ireland-based authorised representative is appointed, they register the device with MHRA in accordance with EU MDR/IVDR requirements.

This ensures that devices are compliant with NI’s hybrid landscape: achieving the CE mark for EU-aligned regulation while meeting UK administrative requirements.

For the complete regulatory guidance, please refer to: