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BHTA: See UK Medical Device Registration and CE/UKCA/NI Marking for an online version of this document and BHTA updates on the new UK regulatory regime as it unfolds; send regulatory queries to info@bhta.com.
BIVDA: BIVDA members can subscribe to the UKCA Sub-Group to receive email alerts relating to new information on the UK regulatory regime as it unfolds. Information is also communicated through the BIVDA Regulatory Newsletter. Regulatory queries can be sent to Regulatory@bivda.org.uk.
PAGB: PAGB members can access detailed regulatory intelligence on self-care medical devices from the PAGB website and subscribe to receive the regulatory intelligence newsletter. For more information on subscribing contact info@pagb.co.uk. Regulatory queries can be sent to regulatory@pagb.co.uk. PAGB also offers a regulatory consultancy service to companies seeking early advice; for example, on the viability of bringing a product to market, understanding requirements for medical device regulation or exploring claims. Contact us about our regulatory and advertising consultancy services. PAGB offers a wide range of training, including workshops, webinars, and eLearning courses such as the EU Medical Devices Regulation eLearning course. PAGB training can be found via the PAGB website.
Exceptional Use Authorisation: In this guidance MHRA outlines how manufacturers can apply for exceptional use authorisation (EUA) which allows non-UKCA/CE certified medical devices to be placed on the UK market when doing so in the interest of the protection of public health. EUAs are granted for a limited time, with conditions to facilitate compliance with relevant medical devices legislation. Once granted, manufacturers must report monthly to the MHRA on supply figures, complaints, adverse events, and progress towards UKCA or CE certification (for EUAs granted for the Great Britain market); or CE certification (for EUAs granted for the Northern Ireland or whole UK market).
European Commission NANDO List of EU Notified Bodies – medical devices: This official EU list shows entries for EU NBs designated under the EU MDR (including national offices of multinational NBs).
European Commission NANDO List of EU Notified Bodies – IVDs: This official EU list shows the entries for EU NBs designated under the EU IVDR (including national offices of multinational NBs).
European Association for Medical Devices of Notified Bodies: TeamNB is the trade association for EU NBs; contact details of their current members) and in-designation members can be found on the Members page.
NB: The European Commission provides a list of hyperlinks to published fees on notified bodies websites. This can be found here.
The UK Market Conformity Assessment Bodies (UKMCAB) database is the definitive source and a register of UK Government-appointed conformity assessment bodies who can certify goods for the Great Britain market. See UKMCAB entries for medical device UK ABs see MHRA – Medical Device UK Approved Bodies for full information, including the scope of AB designation per company, i.e. whether it covers medical devices and/or IVDs.
Association for Approved Bodies: Team-AB is the trade association for UK Approved Bodies.
Manufacturers can access the GB market either through UKCA certification or via recognition of CE certification until July 2028 for general medical devices, or July 2030 for IVDs, depending on the applicable EU legislation.
The UK government is pursuing proposals for comprehensive reform of devices regulation under UKCA. In the meantime, the current Medical Devices Regulations 2002 continue to apply. Devices in NI remain subject to different arrangements under the Windsor Framework, with ongoing alignment to EU rules.
In light of the government’s July 2025 response to its consultation on medical device regulation, and the planned introduction of a new UK medical device regime in 2026, CE-marked devices may continue to be placed on the GB market during the transitional period. The government has also announced plans to consult later in 2025 on indefinite recognition of CE-marked devices.
Additionally, the government intends to remove the mandatory requirement for UKCA marking on devices and associated labelling that have undergone UK conformity assessment. This change will be conditional on the assignment of a Unique Device Identifier (UDI), which must be searchable in a publicly accessible database expected to be operational in 2026.
Transitional Arrangements notwithstanding, manufacturers are able to obtain UKCA Certification currently. As outlined in Sections 2-5 above, obtaining a UKCA mark is materially similar to obtaining a CE mark – the main difference being that the Declaration of Conformity (for self-certified Class I devices or general IVDs) or Assessment Certificate (for 3rd-party assessed Class I Special Function, Class II-and-above device, self-test IVD, IVD included in Annex II list B, or IVD included in Annex II list A) is issued by a UK Approved Body (UK AB) rather than an EU Notified Body (EU NB) against UK MDR 2002 (as amended).
For more information on UKCA marking, please see:
The Role of the UK Responsible Person (UKRP): See this guidance for the roles and responsibilities of a UKRP, which could form the basis of a contract between a manufacturer and a UKRP; in summary, a UKRP must:
UK Responsible Person Association (UKRPA): The UKRPA is an alliance of providers of UKRP services. If you wish to find a professional UKRP, the email addresses of members can be found on the UKRP Members page.
European Association of Authorised Representatives (EAAR): The EAAR is an alliance of providers of EU Authorised Representative (EUAR) services. When placing devices on the EU or Northern Ireland markets, manufacturers from GB or other countries outside the EU must appoint either an EU-based or NI-based authorised representative[5]. If you wish to find a professional EUAR, the email addresses of members can be found on the EAAR Members page.
[5] NB, there are some companies that provide both UKRP and EUAR services; in instances where these companies have a registered office in Northern Ireland, it is possible that a UKRP and EU authorised representative could be the same entity.
MHRA – Guidance on Legislation for IVD Medical Devices: Thorough guidance on how the legislative requirements apply to IVDs, including explanation of classifications and conformity structure.
MHRA – Guidance on Class I Medical Devices: Although derivative of the full guidance in Sections 7-8 above, this advice on Class I medical devices – eligible for self-certification in most cases because of their low risk profile – is a useful guide; e.g. MHRA lists areas that must be covered by a manufacturer’s Technical File; in summary these are:
MHRA is the UK regulator for medical devices. It performs market surveillance of medical devices on the UK market and is able to take a decision regarding the marketing and supplying of a device in the UK. MHRA are also responsible for the designation and monitoring of UK conformity assessment bodies. For medical devices, these approved bodies are organisations that have been designated by MHRA to assess whether manufacturers and their medical devices meet the requirements set out in relevant UK medical device regulations.
MHRA – Regulating Medical Devices in the UK
This guidance sets out what is required to place a medical device on the GB, NI, and EU markets, and what MHRA does within each of these processes. This is the best overview from which to understand the medical device regulatory landscape, with sub-sections on:
MHRA – Post market Surveillance
In addition to the above guidance, MHRA has published a collection of guidance which covers post marketing surveillance information for manufacturers placing products on the GB market. This collection provides guidance on the measures that came into force on 16 June 2025, related to the SI laid in 2024 – The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. While these provisions are similar in intent to EU PMS requirements, there are important differences in scope and implementation. Manufacturers therefore need to ensure that their systems and documentation meet the specific UK requirements in addition to EU obligations, as compliance with one framework does not automatically demonstrate compliance with the other. The collection includes:
The main changes introduced by the amended PMS legislation include:
MHRA – Register Medical Devices to Place on the Market
Before a device can be placed on the market in the UK it must be registered with the MHRA. This guidance sets out how to register medical devices with MHRA for devices intended for the GB and NI markets. This is the best overview from which to understand the medical device registration journey with MHRA, with links to different parts of the process, including:
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with MHRA before they can be placed on the GB market. A registration fee is required, more information on registration fees can be found in Section 2.
It is possible under UK and EU legislation [4] to combine medical devices together into a procedure pack. In the retail sector, this is most commonly seen in first aid kits, but it is not limited to this application. It is atypical to see the kit/pack as a whole CE/UKCA marked (indeed it is prohibited to do so except in some limited and rare circumstances), but any individual medical device product contained in the kit/pack should be CE/UKCA marked. It is therefore necessary to verify each individual component within a kit/pack for compliance. The CE/UKCA mark only applies to medical devices, and kits/packs may contain non-medical device products.
A full list of registration information – Organisation Details (mandatory); Importer Details (if applicable); General Device Details (mandatory); IVD Details (if applicable) – is available from MHRA as an Excel spreadsheet at Manufacturer and Device and Product and Importer Attributes.
For each manufacturer, required details include:
For each device, required details include:
Further guidance is provided for the registration of reusable or unclassified (those devices whose classification will change to a higher risk classification on implementation of the EU MDR) and/or devices relying on expiring CE certificates can be found here:
* ‘up-classified’ refers to a situation where a device that was placed in a lower risk class under the Medical Devices Directive (MDD 93/42/EEC) is now placed in a higher risk class under the Medical Devices Regulation (MDR (EU) 2017/745)) as a result of stricter MDR classification rules.
A Manufacturer or UKRP must create an account on MHRA DORS before beginning to register medical devices with MHRA.
MHRA will email account applicants to confirm whether any account request has been accepted or rejected.
NB: You will not be regarded as registered with MHRA until you have provided detailed information required at registration. Before placing devices on the market, you must ensure all information registered with MHRA is accurate and up to date; MHRA may request additional technical documentation from you to demonstrate your products conform to the relevant regulatory requirements before your registration is confirmed.
To set up an account:
A statutory fee of £261 applies for each registration application.
Registrants can register up to 100 devices (GMDN) with a cumulative maximum of 20,000 products (UDI-DI, medical device name, model or version, catalogue/reference detail) within each application.
If registrants need to update any information within an existing registration, a statutory fee is applicable.
Following the MHRA consultation on statutory fees – proposals on ongoing cost recovery, and extensive stakeholder feedback, the government has revised its approach to medical device fees.
The previously proposed £210-per-GMDN annual fee will be replaced with a new £300 annual fee, applicable per GMDN Level 2 category (or Level 1 where Level 2 does not exist). This new fee structure will replace the current one-off £261 registration fee and will come into effect on 1 April 2026, instead of April 2025 as originally planned. The change aims to support post-market surveillance (PMS) activities. Approximately 60% of manufacturers are expected to pay only a single charge. All fees will continue to be paid via DORS. More information can be found within the government response to the consultation.
Until the new fee structure comes into effect on 1 April 2026, the statutory fee of £261 applies for each registration application applies.
MHRA encourages regular review of device registrations and sets out here their program of review notification within the DORS system.
MHRA sets out here which changes to device registration – including address, company name, additional devices, change of UKRP – are chargeable.
Please see Sections 3 & 4 above for details of EU revision of EU MDD-to-EU MDR transitional arrangements, steps required to rely on an expired CE certificate that has been deemed valid under EU MDR, and Transition Date Matrix.
See also specific MHRA guidance on:
Please see Sections 3 & 4 above for details of EU revision of EU MDD to EU MDR transitional arrangements, steps required to rely on an expired CE certificate that has been deemed valid under EU MDR, and Transition Date Matrix.
See also specific MHRA guidance on:
Once manufacturers and/or UKRPs have registered themselves and their devices with MHRA, registrants’ name, address, and device information are added to the Public Access Registration Database (PARD) for Medical Device Registration. Basic search functionality allows searches by Medical Device Type or Manufacturer Name. Advanced Search functionality allows searches by:
MHRA has published extensive reference guides on:
Likewise, MHRA has produced and makes available a collection of video tutorials on Account Management, Device Registration, and the Certificates of Free Sale System. Finally, MHRA is contactable for queries on device.registrations@mhra.gov.uk.
For enquiries relating to compliance issues for medical devices contact: Devices.compliance@mhra.gov.uk
Other useful guidance on specific types of device Coronavirus Test Device Approval (CTDA) and Registering with MHRA.
In particular, see MHRA Guidance for Industry and Manufacturers: COVID-19 Tests and Testing Kits and underlying legislation at The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (No. 910).
In-house manufacture of medical devices in GB – this provides the legal requirements healthcare establishments should comply with when manufacturing medical devices in-house in Great Britain.
Guidance on applying human factors for medical devices
Custom-made medical devices – This guidance explains how to comply with the regulatory requirements for manufacturing custom-made medical devices.
Digital Mental health technologies – This guidance relates to the regulation and evaluation of digital mental health technology (DMHT).
Clinical investigations for medical devices – this provides guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
[4] For full detail, see UK MDR Regulation 14, MDD Article 12 and EU MDR Article 22.
To determine if a product is a medical device and, if so, into which class it fits (as per Section 2), the following sources of information can be used.
MHRA Guidance:
This provides a comprehensive overview of how MHRA makes decision on whether a product is a medical device and which risk class should apply. It also includes information on how to get advice about your product from the MHRA and provides links to other borderline guidance.
MHRA guidance to assist in determining whether a product falls within the definition of a medical device for the purposes of UK legislation/regulation. See especially, Section 5 – Assistive technology products (aids for daily living):
Equipment intended for alleviation of, or compensation for a disability may or may not be considered medical devices. The determining factor will be whether or not there is a direct link between the corrective function of the equipment and the individual concerned and whether there is a stated medical purpose. The following products are considered to be medical devices as there is such a direct link:
Other products, however, will be considered as ‘general equipment’ since it may be used ‘by all’ (rather than having a direct link with the individual concerned). Such products are usually considered as ‘aids for daily living’ and are not medical devices, for example:
MHRA further defines what it considers a medical device in the context of assistive technologies. In addition to the examples in the borderlines guidance above, see especially its definitions of:
Assistive technology products that are medical devices:
Aids to daily living products that are not medical devices:
To determine if a product is an IVD and, if so, into which class it fits.
If, after reviewing the guidance above, clarification is still required as to whether a product is a medical device, or into which risk class a medical device falls, you may email devices.borderlines@mhra.gov.uk including full details of the product, its intended purpose and how it works.
EU Guidance:
Explains borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative. Clarifies when something is a medical device vs a medicinal product under the new MDR (2017/745).
Covers risk classification of medical devices.
Represents the agreements reached by the EU competent authorities (Borderline & Classification Working Group) under the MDCG, useful reference to previous borderline decisions.
[3] UK law – Medical Devices Regulations 2002 (SI 2002 No. 618, as amended (UK MDR 2002)) – defines “medical device” as:
An instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which—
(a) is intended by the manufacturer to be used for human beings for the purpose of-
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
(iii) investigation, replacement or modification of the anatomy or of a physiological process, or
(iv) control of conception; and
(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.
The MHRA Regulating Medical Devices in the UK guidance sets out MHRA’s requirements (see Section 7) as augmented by April 2023 MHRA Implementation Guidance, press statements, and Statutory Instrument (including Explanatory Notes), It can be summarised as follows:
A Transition Date Matrix showing transition dates based on device class and legislation under which a device is currently registered is available on the next page. See also the June 2023 MHRA Infographic of the timelines for placement of CE-marked medical devices on the GB market.
| Device Class | Law | NI Market Transition (CE, MDD-MDR) | GB Market Transition[2] (CE to UKCA) | Conditions |
|---|---|---|---|---|
| Class III; Class IIb implantables (not sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors) | EU MDD | 31-Dec-27 | 31-Dec-27 | Certificate must have been valid on 26 May 2021; expired certificates must be deemed valid by EU (MHRA requires “EU MDR Article 120 Letter” declaring key conditions for certificate extension are met); this will apply to system and procedure packs if they contain a device in these classes. |
| Class IIb (non-implantable) and sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors; Class IIa; Class Is; Class Im | EU MDD | 31-Dec-28 | 30-Jun-28 (or Cert expiry, sooner of) | Certificate must have been valid on 26 May 2021; expired certificates must be deemed valid by EU (MHRA requires “EU MDR Article 120 Letter” declaring key conditions for certificate extension are met); although certificate validity will be extended to 31 Dec 2028 under EU MDR, these devices can only be placed on GB market until 30 June 2028 (for devices for GB market, new expiry date should be entered as “30-Jun-28”); this will include system and procedure packs that contain such devices unless they also include a Class III or Class IIb implantable device (in which case the validity date will be 31 Dec 2027 for NI, 30 June 2028 for GB). |
| Up-Classified Class I req. NB for EU MDR | EU MDD | 31-Dec-28 | 30-Jun-28 | Dates relate to validity of Declaration of Conformity. |
| Class III, Class IIb, Class IIa | EU MDR | N/A | 30-Jun-30 | Technically, manufacturers may already apply a UKCA mark (for GB) to devices by working with UK ABs to obtain certification against UK MDR 2002. |
| Class I | EU MDD | N/A | N/A | EU MDD-to-MDR transition period for Class I devices not requiring NB involvement has expired; ergo, only devices with DoC to MDR should be placed on the GB market. |
| Class I | EU MDR | N/A | 30-Jun-30 | For Class I devices that are not up-classified and do not require NB involvement under EU MDR; technically, manufacturers may already apply a UKCA mark (for GB) to devices with DoC to UK MDR 2002. |
| Device Class | Law | NI Market Transition | GB Market Transition (UKCA) | Conditions |
| Class I-III medical devices | UK MDR | N/A | TBC | Transition dates to the new regulatory regime are expected to be provided in an SI to be laid before 1 July 2025 covering the balance of new medical device regulations; it is likely transition dates will be tied to the date this SI comes into force or the Inception Date of the new UK regime (expected 01-Jul-25). |
[2] Note: International reliance framework, to be introduced in 2025 will provide an alternative certification to UKCA marking in the GB, see section 2.
| IVD Class | Law | NI Market Transition (CE, IVD-IVDR) | GB Market Transition (CE to UKCA) | Conditions |
|---|---|---|---|---|
| Re-Classified to Class D | EU IVDD | 26-May-25 | 26-May-25 (or Cert expiry, sooner of) | Certificate or declaration of conformity must have been valid on 26-May-22; transitional arrangements for EU IVDR are based on the product risk classification under the EU IVDR |
| Re-Classified to Class C | EU IVDD | 26-May-26 | 26-May-26 (or Cert expiry, sooner of) | Certificate or declaration of conformity must have been valid on 26-May-22; transitional arrangements for EU IVDR are based on the product risk classification under the EU IVDR |
| Re-Classified to Class B or Class A (sterile) | EU IVDD | 26-May-27 | 26-May-27 (or Cert expiry, sooner of) | Certificate or declaration of conformity must have been valid on 26-May-22; transitional arrangements for EU IVDR are based on the product risk classification under the EU IVDR |
| General IVDs (that do not require involvement of a NB under EU IVDR) | EU IVDD | N/A | 30-Jun-30 (or Cert expiry, sooner of) | Declaration of conformity to IVDD requirements must have been made before 26-May-22 |
| Class D Class C Class B Class A (sterile) Class A | EU IVDR | N/A | 30-Jun-30 | No conditions |
| IVD Class | Law | NI Market Transition | GB Market Transition (UKCA) | Conditions |
| General IVDs, self-test IVDs, IVDs listed in Annex II list B, IVDs listed in Annex II list A | UK MDR | N/A | TBC | Transition dates to the new regulatory regime are expected to be provided in an SI to be laid in 2025 covering the balance of new medical device regulations; MHRA have indicated that they would like to establish a transitional arrangement for UKCA marked devices which will allow, at a minimum, products to be placed on the market until either the certificate expires or for 3 years after the new regulations take effect (in the case of general medical devices) or 5 years (in the case of IVDs), whichever is sooner. |
| 2020 | 31 Jan | UK leaves the EU |
| 2021 | 01 Jan | UKCA mark introduced |
| 2021 | 16 Sep | MHRA consultation on the new regulatory framework launched |
| 2021 | 25 Nov | MHRA consultation on the new regulatory framework closed |
| 2022 | 26 Jun | Government response to the consultation on the new regulatory framework with future intentions |
| 2022 | 25 Oct | Notice of intention to amend transitional arrangements |
| 2023 | 27 Apr | First SI introduced to UK parliament |
| 2023 | 08 Jun | First SI approved |
| 2023 | 30 Jun | First SI comes into force |
| 2023 | 26 Jul | PMS SI published on WTO website |
| 2023 | 14 Nov | SI for NI laid in UK parliament |
| 2024 | 09 Jan | MHRA roadmap on future regulatory framework published |
| 2024 | 05 Mar | MHRA holds regulatory reform webinar |
| 2024 | 21 Mar | MHRA consultation on common specifications for IVD devices published |
| 2024 | 21 May | MHRA published draft policy on International Recognition |
| 2024 | 21 Oct | Draft PMS SI laid in UK Parliament |
| 2024 | 14 Nov | MHRA consultation on routes to market and IVDs published |
| 2024 | 11 Dec | MHRA published revised roadmap towards the future regulatory framework |
| 2024 | 16 Dec | PMS SI signed into law |
| 2025 | 05 Mar | MHRA response to consultation on statutory fees |
| 2025 | 24 May | Medical Devices (Amendment) (Great Britain) Regulations 2025 in force |
| 2025 | 16 Jun | PMS SI in force and updated guidance published |
| 2025 | 16 Jul | Uplifted MHRA fees took effect |
| 2025 | 22 Jul | Government response to routes to market and IVD devices consultation published |
| 2025 | 31 Jul | MHRA issued policy intent for an Early Access Service for innovative medical technologies |
| 2025 | 03 Sep | Updated Government response on statutory fees published |
MHRA has published a roadmap to the implementation of the medical device future regime which includes a forward-looking roadmap and other resources:
Post-Brexit, the UK has allowed CE-marked medical devices to remain on the UK market. In GB, this is for a transitional period (see below and Section 4), and under the Windsor Framework Agreement , CE marking will be required for medical devices being sold in NI. Under European requirements (EU MDR 2017/745), medical devices are required to demonstrate compliance by display of a CE mark to be sold legally in the EU (and for as long as the CE mark continues to be accepted in the UK). See MHRA: Medical devices: EU regulations for MDR and IVDR (Northern Ireland) for CE requirements to place products on the NI market, including importer and registration obligations.
Qualifying NI goods may continue to be placed on the market in GB on the basis of a valid CE marking on an indefinite basis. This arrangement is as a result of the government’s commitments to Northern Ireland’s unfettered access to the market in the rest of the UK, and is underpinned by the UK Internal Market Act 2020.
On 21 May 2024, MHRA published a statement of policy intent for international recognition of medical devices, which provides for new, future routes to placing a medical device on the GB market via a certificate of International Reliance (IR). This draft policy indicates that a framework will be established to allow for reliance on assessments performed by comparable regulator countries (CRCs), resulting in a certificate of international recognition, which will allow the medical device to be placed legally on the GB market. The table below indicates the CRCs which are to be included in the envisioned IR framework.
| Country or Jurisdiction | Regulatory Authority |
|---|---|
| Australia | Therapeutic Goods Administration (TGA) |
| Canada | Health Canada |
| European Union (EU) | National competent authorities in the member states of the EU/ European Economic Area (EEA) |
| United States of America (USA) | Food and Drug Administration (FDA) |
MHRA intend to proceed with implementing the proposed international reliance routes. The proposed framework would provide an IR certificate that will grant devices access to the GB market, but it will not provide a UK Conformity Assessed (UKCA) marking, or UKCA certification. If, for the purposes of placing a device on the GB market, an IR certificate was issued based on an EU CE certification, the device could also be placed on the NI market. Given the feedback to the consultation, there will be further consultation on the indefinite acceptance of CE marking. The finalised IR framework and accompanying operational guidance are expected in 2026. IR routes will not open until the new UK medical device regime comes into force, also in 2026. In the meantime, for more detail, please see the MHRA Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices, and the Government response to international reliance, UKCA marking and in vitro diagnostic devices consultation proposals.
UKCA Marking
Where a medical device is placed on the GB market, by demonstrating compliance with the UK MDR 2002 (as amended), a UKCA mark should be displayed. UKCA marking is not currently mandatory for medical devices placed on the GB market, but will become so on expiry of the transitional periods, introduced by MHRA’s Spring 2023 Statutory Instrument (SI) (see Section 4 for full detail). Under the new UK regulatory regime, planned to be introduced in 2026, regulatory requirements in GB will be similar to those introduced by EU MDR/EU IVDR. Medical devices in GB, after a transition period, will be required to demonstrate compliance against these updated regulations either by undergoing a UKCA assessment procedure or through the international reliance procedure.
As outlined in the MHRA Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices, devices that have undergone the UK conformity assessment process may no longer be required to carry a UKCA mark or associated labelling to be placed on the GB market once the 2026 regulation update comes into force.
UKNI Marking
Under the terms of the Windsor Framework Agreement, from 1 January 2021 the rules for placing medical devices on the NI market will differ from those applicable to GB. As a result, the EU MDR and EU IVDR applied in NI from 26 May 2021 and 26 May 2022, respectively, in line with the EU’s implementation timeline. To apply a CE mark, high-risk medical devices and IVDs require review from an EU Notified Body. However, where a UK assessment body has provided an assessment in line with EU MDR or EU IVDR, a UK Northern Ireland (UKNI) mark can be applied for the purpose of placing the device on the NI market. MHRA guidance states:
“UK Notified Bodies can apply to be designated under the relevant EU legislation for the purposes of conducting conformity assessments for the Northern Ireland market. Please note that there are currently no UK Notified Bodies designated to undertake such assessments under the EU MDR or the EU IVDR. This section outlines the criteria for affixing a UKNI marking to devices should any UK Notified Bodies be designated in future. In addition to the CE marking, device manufacturers will also need to apply the UKNI indication if they choose to use a UK Notified Body (should any be designated in future) for mandatory third-party conformity assessment. Device manufacturers must never apply the UKNI indication on its own – it must always accompany a CE marking.”
Transitional arrangements (see Section 4) mean the CE mark will continue to be accepted to place medical devices on the UK market for the immediate future (until as late as June 2030 in some cases).
Medical devices fall into the following five groups across three classes:
IVDs vary hugely from medical devices (despite being a sub-category of medical device) and therefore, these products have a different classification structure.
Under the UK MDR 2002 (as amended), IVDs fall into the following four groups across three classes:
Class I devices and general IVDs are “self-certified”; a manufacturer is responsible for assembling and maintaining technical files and other compliance documents in line with the regulations and then makes a Declaration of Conformity (DoC) per product. The DoC is lodged with the relevant national regulatory authority (MHRA in the UK), which may ask to examine technical files. A DoC lasts for as long a product remains “substantially unchanged” in design, purpose, or application. As of 2022/23, the costs for placing a class I device or general IVD on the UK market (exclusive of companies’ own regulatory/compliance staff overheads) can be estimated as follows:
Class I special function (measuring, sterile or reusable), all class II and above devices, self-test IVDs, IVDs included in Annex II list B, and IVDs included in Annex II list A are “3rd party assessed”; a manufacturer must obtain and maintain a CE or UKCA certificate through an EU Notified Body (NB) designated by an EU Member State or UK Approved Body (AB) designated by MHRA. EU NBs and UK ABs are independent companies appointed under law by a relevant national authority which provide 3rd party technical and compliance assessment. Provided a product remains “substantially unchanged” in design, purpose, or application, a certificate lasts for a set period of time (e.g. 3-5 years), after which 3rd party re-certification must take place to verify continued conformity.
As of 2025/26, the costs for placing a class I special function, class II-and-above device, self-test IVD, IVD included in Annex II list B, or IVD included in Annex II list A on the UK market (exclusive of companies’ own regulatory or compliance staff overheads) might be estimated as follows:
On 02 September 25, MHRA published an update to the Government Response to the MHRA Consultation on Statutory Fees for medical devices.
The response outlines the final proposals for the introduction of a new annual fee to support post-market surveillance (PMS) activities for medical devices. This follows extensive consultation with stakeholders across the sector the including responding to the challenges raised to the initial government fee proposals. The revised approach reflects feedback from industry, including trade associations, and trusted advisor groups, and aims to ensure a fairer distribution of costs while safeguarding patient safety and supporting innovation.
The new fee structure will come into effect from 1 April 26, with further guidance and support to be published in the coming months to help the medical devices community to prepare. Important updates are:
Medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No. 618, or UK MDR)[1]. This secondary legislation translated into UK law the 1990 EU Active Implantable Medical Devices Directive (EU AIMDD), 1993 EU Medical Device Directive (EU MDD), and 1998 EU In Vitro Diagnostic medical device Directive (EU IVDD). Following Brexit, UK MDR has gone through a series of amendments.
EU MDD and EU AIMDD were superseded by the 2017 EU Medical Device Regulation 2017/745, or EU MDR, while EU IVDD was superseded by the 2017 EU In Vitro Diagnostic medical device Regulation 2017/746, or EU IVDR. Because EU MDR and EU IVDR post-dated the Brexit transition period, it was not automatically retained in the UK, by the EU (Withdrawal) Act 2018.
However, the EU MDR and EU IVDR are still relevant to the UK. Market access for UK medical devices is governed by its application for both access to Northern Ireland (NI) and where the Conformité Européene (CE) mark is applied. Since 26 May 2021, the EU MDR has applied in the EU and NI as a consequence of the Windsor Framework Agreement (previously known as the Northern Ireland Protocol), while EU IVDR has applied in the EU and NI since 26 May 2022. The EU MDR and EU IVR also apply in Great Britain (GB) where a CE marked device is placed on the market (see Section 2).
[1] Pre-Brexit, this gives/gave effect in UK law to: 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).