Regulations
Last Updated: 07 August 2026
The medical device industry and the United Kingdom requires the knowledge that the devices in the UK are regulated under the UK Medical Device Regulations 2002, enforced under the consumer protection act 1987. The EU MDR and EU IVDR do not apply in GB where there is close alignment to the old requirements and the deadlines for transitioning of the older directive devices are June 30, 2028 while additional deadlines of two years have been made available till 2030. However, when selling in Northern Ireland then the European regulations would be applied directly under the Windsor framework. To enter Great Britain, UK MHRA will allow you to apply for UKCA or transitional CE markings but for Northern Ireland you would have to have valid CE marking or even combined CE UK(NI) marking if you apply through a UK body. Approvals from overseas regulatory agencies such as US FDA are not recognized by the UK MHRA at all so you need to comply with the relevant routes anyway.
If you are a manufacturer based outside the UK then you need to appoint only one representative prior to selling anything. In the case of Great Britain, you need to appoint the UK Responsible Person who has to be located in Great Britain to serve the UK MHRA. The UK Responsible Person needs to verify your Declaration of Conformity and technical documentation to ensure their correctness and to hold copies available for possible inspection by the UK MHRA. The UK Responsible Person also conveys any sample or information requests made by the regulator, and he/she must end the agreement in case of manufacturer’s violations of the law. In the case of Northern Ireland, you will be considered as a third party and therefore need to appoint an Authorized Representative located in the EU or NI. Another important point to mention about the accounting logistics within the system: those representatives’ accounts which failed to transfer in 2022 were frozen. In case you fail to rectify the situation until the last deadline, March 30 2026, the UK MHRA will close your account for good and you will have to open a new one from scratch.
Device Classification and MHRA Medical Device Registration
Your product should meet the criteria of being defined as a medical device or diagnostic. Then it is classified according to its risk level, after which the UK MHRA can apply MHRA medical device regulation guidelines to evaluate it. General devices are divided into Class I, Class IIa, Class IIb, Class III, while the highest risk requirements are reserved for active implantable devices. In vitro diagnostics are divided into general, Annex II List A, Annex II List B or self test. Low risk non sterile Class I devices and general diagnostics can be self certified by the manufacturer, while other classes require the involvement of a third party (UK Approved Body in GB or EU Notified Body in Northern Ireland). For high risk diagnostics the products must be examined by the approved bodies on a very strict batch by batch basis. Your physical labels must bear either UKCA or CE mark with the body number. If you choose the UKCA route, then you need to put the name and address of the UKRP on your label or packaging, while CE only transition does not need it.
Registration Portals and UK Medical Device
Registration Fees Devices, diagnostics, custom packs etc must be registered at the UK MHRA before you start selling them. Mandatory process of MHRA Medical Device Registration according to section 7d costs £300 per each Level 2 GMDN category or Level 1 if there is no Level 2 for your product. For Northern Ireland you need to register your entity as an actor in the European EUDAMED database with EORI number and trade register information. Modules of actors, devices, notified bodies and market surveillance became mandatory on May 28 2026, while post market and clinical modules became mandatory right when they went down without any voluntary period. Distributors do not have to register themselves as actors in EUDAMED. Custom made devices for NI bypass EUDAMED registration and get registered in domestic DORS in 28 days from being made available. If the NI manufacturer already registered in the UK MHRA as a local market actor, then he can sell his products in Great Britain without additional registration and fees.
Clinical Investigation Paths and UK Medical Device Registration
In case you plan to conduct any kind of clinical investigation of general and active implantable devices within the UK then you need to submit notification 60 days prior to the initiation of clinical investigation process under MHRA medical device regulation standards to UK MHRA. This 60 day notification does not pertain to diagnostics, but you still need to inform about the performance evaluations. Application fees are determined under section 7a according to the risk of the device as follows: for Class I, IIa and non high risk IIb the application fee will be £15,309 while for resubmission it will be £11,701; for high risk IIb, Class III and active implantables the application fee will be £32,016 while resubmission will cost you £22,678. In order not to lose your money you can schedule some pre submission routes such as statistical review for £852 or regulatory advice for £987.
Special Provisions for Combination Products
Device combination products which incorporate medicinal substances are subject to special consultation fees according to section 8 based on the origin of the medicine. The fees are £4,953 with £980 follow ups for known substances of approved origin, £11,543 with £2,668 follow ups for known substances of novel origin and £50,644 with £12,574 follow ups for a totally new active substance. They are subject to multi substance rules and thus, if there are two or more medicinal substances then the entire fee would be set at the highest level but the price would not change irrespective of the dose concentration. You may be able to group together similar devices with the same medicine in one fee if submitted at the same time. In bodies seeking to widen their scope for these combination products, an assessment by the Secretary of State costs £19,824 whereas extensions for already designated sections costs £13,684 and subsidiary audits costs £24,806 plus travel.
International Recognition and Parallel Imports
In case your product lines consist of different categories of international recognition or parallel import routes, the charges from sections 14 and 16 will be as follows:
International recognition major type B: £83,580
International recognition major type A: £24,688
Abridged complex international recognition type B: £23,205
Abridged complex international recognition type A: £13,983
International recognition standard type B: £8,503
International recognition standard type A: £7,743
Cost of parallel imports for cross border device medicinal products: £2,400 simple applications; £10,617 standard applications; and £24,343 complex applications where there is no common origin between the import and the UK reference product.
Technical Validation and Approved Body Audits
For foreign companies that may need external auditing, the scheme states the amount of fees to be paid to Approved Bodies for such purpose as below:
Application for initial designation: £41,337
Initial designation audit fee: £67,606
Surveillance audits: £52,929
Witness audits: £11,672
Audit after major closure: £26,408
Clinical follow up audit: £21,535
Special process or subsidiary audits: £26,408
TSE application review: £1,503 (only if device involves material which is susceptible to TSE)
Extension of scope: £21,105 (if a new code is applied) or £14,568 (if code numbers are limited)
Fees payable for physical/paper audit outside of scope will be as per operational cost of £1,463 per day.
UK Medical Device Regulations and the International Recognition
The IRP of the UK demands proper planning under MHRA medical device regulation policies if your medicinal product requires an integral device or any external diagnostic. According to the statutory UK Medical Device Regulations, the preparation of the components of such a device is crucial throughout the submission period. Missing the conformity standards leads to automatic failure of your submission to be included in the faster 60 days Route A and makes it fall into the 110 day Route B procedure.
Three Triggers for the Route B The submission process will face this 50 days delay in case of the following reasons:
Missing Marks: Co packaged medical device components do not possess a valid CE or UKCA mark.
Uncertified Diagnostics: The In Vitro Diagnostic (IVD) required in your application is unapproved.
No Evaluation Report: You cannot submit an official evaluation report from an authorized body for the integral components.
Importer Obligations for Northern Ireland
Under the article 13 of the MDR and IVDR, the importer of foreign medical devices should technically confirm the presence of a CE mark, declaration of conformity, identification of the manufacturer, appointment of a representative and assigning of UDI of the imported devices. The importers have to write their own names and addresses on the device labels and should store the conformity certificates for at least 10 years or 15 years if it is an implantable product.
Post Market Surveillance and UK Medical Device Registration Requirements
Manufacturers have to submit comprehensive vigilance reports to the MHRA in case of any bad incidents happening in the UK and do field safety corrections rapidly.In Great Britain, the post market surveillance under MHRA medical device regulation policies was improved by the laws effective from June 16 2025 to monitor incidents more effectively. For Northern Ireland, you will report incidents through the MORE system and doctors report through the Yellow Card portal. According to article 10a, if you expect a supply interruption or discontinuation that may affect public health, you have to inform the MHRA and your buyers at least 6 months in advance. There is an exception that says that any expected interruptions that occurred before January 10 2025 do not have to be reported even if the actual supply disruption occurs after this date.
Extended CE Transitional Timeline under UK Medical Device Regulations
If your products use EU CE mark instead of UKCA mark, the UK government extends the deadlines to enter the Great Britain territory according to the guidelines outlined in the UK Medical Device Regulations.
Old EU MDD or AIMDD devices: Allowed until the expiry of the certificate or June 38, 2028 whichever comes earlier (Class I sterile and measuring devices)
Old EU IVDD diagnostics: Allowed until the expiry of the certificate or June 30, 2030
New EU MDR or IVDR devices: Full access to Great Britain until June 30, 2030
CE marked devices that were self declared without involvement of notified body (under old directive) are allowed if the declaration was made prior to May 26 2021 and is still valid due to EU transitions. CE self declaration of the diagnostic is allowed if it was made prior to May 26 2022. Class I devices with self declaration under the new EU regulations are valid until June 30, 2030. Class I devices re classified under newer regulations as those requiring a notified body (such as reusable surgical instruments) are extended until June 30, 2028 if they were self declared prior to May 26 2021. The extended certificates under EU legislation can be used for registration and sale of devices in Great Britain and Northern Ireland until their new transition dates.
Application for Certificate of Free Sale for medical devices costs £75 per certificate in case of the first 10 certificates and £10 per each additional certificate in one order. Fees for Northern Ireland remain the same for designation and monitoring of notified bodies and free sale certificates. In case of disputes with the final decision of the licensing authority regarding your device or combination application, you have a right to appeal the decision and ask for Review Panel Hearing under the Human Medicines Regulations 2012 for an upfront fee of £11,974. The refund policy states:
You will receive a 100% refund if you win and your decision is overturned.
You will receive a 60% refund if you withdraw from the hearing before the review panel is formally constituted.
You will receive a 0% refund and you will lose all your money if you withdraw from the hearing after the panel is constituted.
What are the exact upfront application fees and remediation costs if an overseas manufacturer must run a local clinical investigation in the UK?
The fees depend on the risk category of the device under section 7a if clinical trials must take place in the UK. The initial clinical trial application fee for Class I, IIa, and non high risk IIb devices is £15,309, and the resubmission protocol fee is £11,701 if remediation is required. For high risk Class IIb, Class III devices, and active implantable medical devices the initial fee is £32,016, and the formal resubmission following remediation is £22,678.
What are the specific timelines and rules regarding supply discontinuations or interruptions that could cause public health harm in Northern Ireland?
If there are interruptions or supply discontinuations that may affect the availability of medical devices in Northern Ireland resulting in serious public health concerns, it is mandatory to notify UK MHRA, and buyers at least six months before the anticipated disruption or discontinuation of supply. There also is a transitional derogation for discontinuation and interruptions of supply before January 10, 2025. This means that there is a temporary exemption to notify if the disruption of supply occurs before January 10, 2025, even if the actual supply disruption occurs after this date.
What are the primary administrative barriers to entry regarding historical representative accounts on the registry system, and what is the final hard deadline for compliance?
All representative accounts that did not transition to a UK Responsible Person on the registration system were deactivated on January 1, 2022, along with their manufacturer accounts. If the transition of your representative account to the UK Responsible Person does not happen by the hard deadline of March 30, 2026, your account will be deleted from the database, and you will need to re establish a UK Responsible Person account afresh from that point onward.
If our device is a drug device combination product, how do the characteristics or number of medicinal substances alter the statutory consultation fees?
There are two special rules for combination products outlined in section 8 of the guidance. The multi substance rule states that if the device incorporates two or more medicinal substances, the consultation fee should follow the category of the higher substance. On the other hand, the concentration invariance rule states that the consultation fee remains the same regardless of the amount, concentration, dose, or strength of the substance incorporated into the device.
What are the financial costs billed to third party validation entities for undergoing initial designation, surveillance, and localized site audits by regulatory auditors?
The Approved Body fees in 7b include £41,337 for the initial designation application and £67,606 for the initial designation audit. The surveillance audit fee is £52,929, whereas the witnessed audit is £11,672. A follow up audit for a major closure is expected to be £26,408 while a special clinical follow up audit or process specific audit is £26,408. The auditing fee outside the specific scope outlined above will be calculated at a daily operational rate of £1,463 per day.
What are the specific document verification, labeling, and storage duration mandates imposed on local importers bringing overseas devices into Northern Ireland?
According to Article 13, the local importer should confirm that the device is CE marked, a declaration of conformity has been issued and that is acceptable, the manufacturer is named, the appointee of a representative has been identified and a UDI is assigned. The local importer will be required to apply his/her name and address on the device’s packaging or the invoice. In addition, the declaration of conformity and certificates should be retained for at least 10 years (or 15 years in the case of implants).
If an overseas manufacturer disputes a licensing or combination application decision, what is the cost of an appeal and how do withdrawal timelines affect refunds?
An overseas manufacturer may initiate a formal appeal to the Review Panel Hearing through human medicines regulations 2012. The fee for the application of the appeal is £11,974 which is required upfront. The refund policy requires a 100% refund if the appeal is successful and the original decision is overturned. A 60% refund is permitted if the appeal is withdrawn prior to the appointment of the specific review panel. However, no refund is available if the withdrawal takes place after the appointment of the specific review panel.
How does the UK Medical Device Regulations framework define the baseline protocol for localized data tracking, and what are the primary administrative steps to complete an initial MHRA Medical Device Registration or a separate UK Medical Device Registration for global product distribution lines?
The default protocol for the tracking of data locally is guided by the UK Medical Device Regulations framework which is used to track local compliance. For the purpose of registering the medical device for the first time, complete the online registration form and attach the GMDN application codes. If the organization runs multiple divisions, UK medical device registration should be done separately to prevent delay with MHRA.