Regulation of Medical Devices and In Vitro Diagnostic Medical Devices in Northern Ireland
The regulation of medical devices and in vitro diagnostic (IVDs) medical devices in Northern Ireland is governed by the Windsor Framework. This means that the EU Medical Device Regulation ((MDR)(EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 have applied in Northern Ireland [1] in line with the respective dates of application across the EU. The Medicines and Healthcare Products Regulatory Authority (MHRA) is the de facto Competent Authority for Northern Ireland and has specific requirements for registration, vigilance reporting etc. [2]
Under the Windsor Framework, [3] businesses in Northern Ireland have unfettered access to the entire UK market. [4] Therefore, Northern Ireland businesses can place qualifying goods [5] on the market in Great Britain with the CE mark (subject to MHRA’s recently updated timelines for acceptance of CE marked devices) or the UKCA mark.
The CE mark indicates conformity assessment against the EU MDR/IVDR, while the UKCA mark indicates conformity assessment against the UK MDR 2002. The UK(NI) mark is used to indicate conformity assessment against the EU MDR/IVDR, when assessment is performed by a UK Notified Body. Medical Devices conformity assessed by a UK Notified Body and bearing the UK(NI) mark alongside the CE marking, may be placed on the NI market but will not be accepted on the EU market [Note: a UK Notified Body is different to a UK Approved Body. To date, no UK Notified Bodies have been appointed].
If a Northern Ireland manufacturer sells a medical device or IVD (UKCA marked or a CE marked) in Great Britain and/or Northern Ireland, they need to register with the MHRA. There is no requirement for a NI manufacturer to appoint a UK Responsible Person (RP) or EU Authorized Representative (AR) for MHRA registration. For selling devices in the EU with a CE mark, Northern Ireland manufacturers need to consider registering with EUDAMED once they have an EU CE mark (EU MDR/IVDR). Registration is encouraged but not yet mandatory. There is no need to appoint an EU AR for EUDAMED registration.
Devices that have been CE marked in the EU can be sold in Northern Ireland. Manufacturers based outside of the UK wishing to sell devices in Northern Ireland [6] can appoint an EU or Northern Ireland-based AR via the Devices Online Registration System (DORS). [7]
GB-based manufacturers placing devices on the NI market must designate an EU AR or NI-based AR. Where an EU-based AR is appointed, the GB manufacturer must register all device classes, other than Class I devices and general IVDs (that are not for self-testing) with the MHRA. Where a NI-based AR is appointed, the NI AR must register all devices with the MHRA. Registration requirements do not extend to Class I medical devices or general category IVDs, and the MHRA has not yet provided guidance on the registration of class A IVDs.
Devices moving from Great Britain to Northern Ireland are considered imports into the EU. If a Northern Ireland business brings goods into the country from Great Britain or another non-EEA country for placement on the Northern Ireland market, they are classified as an importer. [8] Importers have specific obligations under the EU MDR/IVDR (Article 13), including ensuring proper marking and registration of declarations.
Under the EU MDR/IVDR, manufacturers and Authorized Representatives based in Northern Ireland are required to have a Person Responsible for Regulatory Compliance (PRRC). [9]
Health institutions in Northern Ireland can follow MHRA guidance [10] or MDCG 2023-1 [11] to benefit from an exemption from the EU MDR/IVDR for devices used within the same legal entity in which they are manufactured.
All clinical investigations involving a site in Northern Ireland must be submitted to the MHRA according to EU MDR requirements. [12] This single application also covers GB sites within the same study, and the MHRA follows EU MDR requirements for assessment, modifications and reporting.
IVD performance studies in NI must meet the requirements of the EU IVDR and can be registered with MHRA via DORS. [13] There is currently no UK requirement to provide information in specific templates as set out in MDCG 2022-19. [14] IVD performance studies that meet the criteria laid in IVDR Article 58 must be authorised by the MHRA, who will assess applications on a case-by-case basis (for IVD performance studies involving companion diagnostics, using only left-over samples, notification will be sufficient).
If a business in Northern Ireland provides diagnostic or therapeutic services to EU citizens, any medical device or IVD used in those services must comply with the EU MDR/IVDR.
Whilst the regulation of medical devices and in vitro diagnostic medical devices in Northern Ireland continues to evolve and can be complex, it may also present business opportunities in Northern Ireland going forward.
[1] https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr
[3] https://www.gov.uk/government/publications/the-windsor-framework
[4] https://www.gov.uk/guidance/moving-qualifying-goods-from-northern-ireland-to-the-rest-of-the-uk
[5] Moving qualifying goods from Northern Ireland to the rest of the UK - GOV.UK (www.gov.uk)
[7] https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
[9] https://health.ec.europa.eu/system/files/2020 09/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en_0.pdf
[11] https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf
[14] https://health.ec.europa.eu/system/files/2023-01/mdcg_2022-19_en.pdf
The Compliance Navigator blog is issued for information only. It does not constitute an official or agreed position of BSI Standards Ltd or of the BSI Notified Body. The views expressed are entirely those of the authors.
