Under certain conditions, the UK MDR 2002 mandates that you notify the MHRA at the time of your device’s initial sale in Northern Ireland. The manufacturer’s location, the Authorised Representative’s location, and the device class determine the specific criteria.
Requirements for Non-UK manufacturers
To sell medical equipment in Northern Ireland, non-UK manufacturers are exempt from the requirement to designate a UK Responsible Person.
To sell devices in Northern Ireland, manufacturers who are based outside of the EU or the EU must designate an Authorised Representative who is based in the EU or in Northern Ireland.
Requirements for Great Britain-based manufacturers placing devices on the Northern Ireland market
To place a device in Northern Ireland, British manufacturers must choose an Authorised Representative with a base in the EU or Northern Ireland.
- Where an EU-based Authorised Representative is appointed, the manufacturer located in Great Britain is required to register with the MHRA all device classes other than Class I devices and general IVDs (those are not for self-testing)
- Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative must register all devices with the MHRA.
How can importers register?
When a product is placed on the Northern Ireland market, the Authorised Representative headquartered in Northern Ireland is required to give the MHRA information on the person doing so if they are not:
- The manufacturer, or
- The Northern Ireland-based Authorised Representative.
How to do the registration of custom-made devices in Northern Ireland?
On the EU market (including Northern Ireland), only devices that are custom-made in accordance with EU MDR 2017/745 are permitted.
Before May 26, 2021, custom-made devices registered under the EU MDD or EU AIMDD and sold in an EU member state other than Northern Ireland may still be registered with MHRA with the intention of being sold exclusively in Northern Ireland.
What are the details needed to register your device with the MHRA?
You are asked to provide the following information when registering your devices
Manufacturer details:
- legal entity name and address as it appears on the device labelling/packaging
- company type e.g., limited company, sole trader
- administrative contact (you can have up to 15 people with access)
- a designation letter (if any) for UK Responsible Persons. This must be a formal contract that identifies you as the manufacturer’s sole UK Responsible Person and outlines the duties you are required to perform under the
terms of the agreement. Our regulatory guidance for UK Responsible Persons contains the necessary responsibilities that need to be included in the designation contract.
Device details:
- which legislation applies
- the class of device you are registering
- Global Medical Devices Nomenclature (GMDN)
- Basic UDI-DI (if applicable)
- medical device name (brand/trade/proprietary name)
- model or version detail
- catalogue/reference number
- UDI-DI (if applicable)
- UK Approved Body (or EU Notified Body) where applicable
- attributes such as sterility, contains latex, MRI compatible