Following the departure of the United Kingdom from the European Union, and as of 1 January 2021, medical devices and in-vitro diagnostic medical devices (IVDs) are now currently regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which has been derived from the below EU legislation:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD).
- Directive 93/42/EEC on medical devices (EU MDD).
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD).
In December 2020, Statutory Instrument 2020 No. 1478 “Exiting the European Union Consumer Protection” was published and came into force on 1 January 2021. The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulating body in the UK for medical devices. You may find the UK MDR 2002 as well as the 2020 Amendments in the below two links:
The Medical Devices Regulations 2002
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020
Device Registration #
As of 1 January 2021, all medical devices (including IVDs, custom made devices, systems and procedures packs) being placed on the Great Britain (GB) market will need to be registered with the UK MHRA. For devices to be registered they must either comply with the UK MDR 2002, the EU Medical Device Regulation 2017/745 (MDR), or the EU IVD Regulation 2017/746 (IVDR).
Furthermore, legacy products with respect to the EU MDR and IVDR will still be accepted. However, all devices being placed on the GB market will need to comply with the UK Regulations by 30 June 2023*. Registrations for devices manufactured outside of the UK will need to be submitted by the UK Responsible Person.
*As of October 2022, the MHRA released a letter to indicate that this shall be postponed to 2024. This post will be updated to include the official statement, once released.
UK Responsible Person (UKRP) #
Manufacturers based outside of the UK who wish to place devices on the UK market will require a UK Responsible Person (UKRP), the appointment of which must be substantiated by written evidence that they have the authority to act on the manufacturer’s behalf. The role and responsibilities of the UKRP are set out in the UK MDR 2002, including:
- Register devices for placement on the UK market.
- Ensure that the declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements.
- In response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device.
- Where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access.
- Where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request.
- Cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed.
- If the manufacturer acts contrary to its obligations under these Regulations:
- Terminate the legal relationship with the manufacturer; and
- Inform the Secretary of State and, if applicable, the relevant notified body of that termination.
The importer or distributor of the goods may also act as the UKRP, however, they will need to meet the obligations listed above. If the GB importer does not take up the role of the UKRP, they will need to inform the manufacturer or UKRP of their intention to import the device. The manufacturer or UKRP will then need to provide the MHRA with the importer details.
From 1 January 2022, all non-UK manufacturers must appoint a UKRP in order to register their devices placed on the GB market.
Northern Ireland #
The Northern Ireland Protocol was set up to facilitate trade and avoid a hard border between Ireland and Northern Ireland, whilst ensuring the integrity of the EU’s Single Market for goods.
Non-UK manufacturers of general IVDs and medical devices will not require a UKRP to place on the Northern Ireland market. However, non-UK manufacturers wishing to place List A, List B, and self-test IVDs on the Northern Ireland market may be required to appoint a UKRP in the following cases:
- Manufacturer based in the EU / EEA.
- IVDs not already registered with an EU Competent Authority.
- Manufacturer based outside the UK, EU, EEA.
- Authorised Representative based outside of Northern Ireland.
GB-based manufacturers placing devices on the Northern Ireland market will be required to designate an Authorised Representative in either the EU or Northern Ireland. If the Authorised Representative is based in the EU, the GB manufacturer will be required to register all devices other than class I devices and General IVDs with the MHRA. Otherwise, the NI-based Authorised Representative will need to register all devices with the MHRA.
The details of the legal person making products available on the NI market must be provided to the MHRA by the NI-based Authorised Representative or the UKRP. In this case, the importer must not be the manufacturer, NI-based Authorised Representative, or the UKRP (IVDs).
Registering Device with the MHRA: Requirements #
The following information (non-exhaustive) must be provided to the MHRA when registering your devices:
- Manufacturer Details:
- Legal manufacturer name and address.
- Company type.
- Administrative contact.
- Letter of designation for UK RP (where applicable).
- Device Details:
- Applicable legislation.
- GMDN code and term.
- Basic UDI-DI (if applicable).
- Device name.
- Catalogue/reference number.
- UDI-DI (if applicable).
- UK Approved Body or Notified Body (where applicable).
- Attributes (sterility, latex, measuring).
- Conformity assessment certification or self-declaration of conformity shall also be provided.
The full list of requirements can be found here.
How Can We Help? #
Getting to terms with and meeting these new requirements are understandably tedious. We can help you put together a Regulatory Strategy to assure access to the UK market and abide by the transitional provisions in place.
You can find additional guidance on this topic, here.