Class 1 medical device self-certification in the UK
What you need to check, prepare and take responsibility for
Before you start Class I self-certification, check whether your software is a medical device and which classification applies. This assessment determines whether you can use the Class I route and what evidence you need to prepare.
For an eligible Class 1 (Class I) device, you demonstrate conformity, sign a Declaration of Conformity and apply the UKCA mark. You also register with the MHRA before placing it on the market. The manufacturer takes responsibility. Registration doesn't mean the MHRA has approved your product.
This guide focuses on software under UK MDR 2002, following the UKCA route in England, Scotland and Wales. It covers non-sterile, non-measuring Class I devices. IVDs, custom-made devices and investigational devices have different requirements. Northern Ireland follows EU rules.
Class 1 medical device requirements in the UK
Start by writing down the software's intended purpose: what it is meant to do, who will use it and the medical claims you're making. Use that description to assess whether it is a medical device and determine its classification. If Class I applies, review your existing evidence and identify what you still need to prepare.
What if only part of our platform is a medical device?
Start with the feature you think is a medical device. What goes in? What comes out? Who uses it, for which patients, and what medical claims are you making? Write down where that feature starts and ends, and how it connects to the rest of your platform.
A separate module still depends on the things around it. Assess shared services where they affect safety or performance. This is how we'd apply MHRA's guidance on intended purpose, operating environment and software modules to a platform.
I'd split the work into two stages:
| Stage | What to assess or prepare | Output |
|---|---|---|
| 1 Work out what you're certifying | Review the features, clinical workflow, product claims and UK classification rules. Check that your proposed device boundary makes sense. | A written intended purpose, device boundary, classification rationale and list of missing evidence. |
| 2 Get the evidence and documents ready | Once ordinary Class I is confirmed, finish the technical, risk, clinical and software evidence. Put ongoing controls in place and close the gaps. | Approved technical documentation, a signed UK Declaration of Conformity, UKCA marking and MHRA registration. |
The assessment might confirm Class I. It might identify a higher class. It might conclude that the feature isn't a medical device at all. Set the scope and delivery dates once you know.
For ordinary Class I, the manufacturer is responsible for conformity. MHRA registration doesn't come with a product approval certificate. Sterile or measuring Class I devices need an Approved Body for those aspects.
Check the UK rules for the route you're taking. UK and EU classifications can differ, and EU MDR Rule 11 can put decision-support software in Class IIa or above. Having a clinician check the output doesn't automatically make it Class I.
How to self-certify a Class 1 medical device: documentation checklist
Give each step an owner in your business. Once you've settled the classification, the risk, engineering and clinical work can run alongside each other. Use the last column to agree what finished means. These are practical completion checks, rather than document titles prescribed by the MHRA.
| Step | What to do | Complete when |
|---|---|---|
| 1 Confirm scope and classification | Describe the module's medical purpose, users, patient population, inputs, outputs and connections to the platform. Check whether it's a medical device and which UK classification rules apply. | You've approved the intended purpose and device boundary, and recorded why ordinary Class I applies. Any borderline questions are settled before you use this route. |
| 2 Find the evidence gaps | Build an Essential Requirements matrix. For each applicable requirement, record the evidence, what's missing, who owns it and when it's due. List the standards you use and explain any exclusions. | Every applicable requirement has evidence or a named action. The people doing the work know what they're responsible for. |
| 3 Record the risks and design | Work out what could go wrong, including misuse, and put controls in place. Record the requirements, architecture, dependencies, configurations and reasoning behind the software safety class. | You can trace each control to its implementation and test evidence. You've recorded the remaining risks and overall benefit-risk conclusion. You've assessed IEC 62304's software safety class separately from regulatory Class I. |
| 4 Test the release | Run the relevant software, integration, usability and security tests. Keep the results and defects, with links back to the requirements and risk controls. | The evidence covers the version you're declaring. You've assessed any unresolved defects, and none prevents conformity. |
| 5 Check the clinical evidence and instructions | Review the evidence behind each medical claim. Decide whether a clinical investigation is needed. Finish the instructions, limitations, warnings and software labelling. | The clinical evaluation supports the intended purpose. Your claims and instructions match the evidence. You've closed the necessary evidence gaps before signing the declaration. |
| 6 Set up the ongoing work | Approve the post-market surveillance (PMS) plan. Set up procedures for feedback, complaints, corrective action and vigilance. Assign owners, reporting triggers, review dates and change controls. | Your team can collect and assess safety information, report when required and reassess product changes. You've scheduled the Class I post-market surveillance report (PMSR). |
| 7 Review, declare and register | Review the completed technical file. Sign the UK Declaration of Conformity, apply UKCA marking and register through the MHRA's Device Online Registration System (DORS). Appoint a UK Responsible Person if the manufacturer is outside the UK. | The declaration identifies the manufacturer, device and applicable legislation. An authorised person has signed and dated it. Marking and registration are complete before market entry. |
Keep these records under version control. A consultant can help prepare and review them, but the manufacturer still owns the declaration. Registering with the MHRA doesn't mean your technical file has been approved.
What does Class 1 medical device certification cost in the UK?
For 1 April 2026 to 31 March 2027, MHRA registration costs £300 a year per relevant GMDN Level 2 category, or Level 1 where no Level 2 exists. Check the current fee guidance for your calculation and any pro-rating.
That fee is one line in the budget. You also need to pay for the work: staff time, testing, clinical evaluation, technical documentation, specialist advice and ongoing surveillance. Get a quote against the gaps in your product. A fixed price means very little until you know what needs doing.
What happens after registration
You'll keep changing the software after launch. The evidence needs to keep up. Maintain the technical file, review complaints and safety signals, report incidents when required and assess product changes.
For a new launch under the GB surveillance rules, prepare the Class I surveillance report within three years of first placing the device on the market or putting it into service, whichever happens sooner. Update it when needed and at least every three years. That's the report deadline, not a reason to leave monitoring until then.
Class 1 self-certification: common questions
Do I need ISO 13485 certification?
An ISO 13485 certificate isn't a universal requirement for ordinary Class I UKCA self-declaration. You still need appropriate quality processes and evidence that you follow them.
Do I need a clinical trial?
You need a clinical evaluation. Whether you need a new clinical investigation depends on the evidence you already have. If it can't demonstrate safety and performance for the intended purpose, an investigation may be necessary.
Can a CE-marked device be sold in the UK?
Eligible CE-marked devices remain accepted during the applicable transition periods. Check the rules for your device and the legislation it meets. Don't assume UKCA is your only route.
Does MHRA registration make us ready for the NHS?
There's more to NHS assurance than device registration. You still need to check the clinical safety, DTAC, data protection and security requirements for your product and buyer. Our NHS supplier compliance requirements guide walks through that wider picture.
Plan your next step with Highguard
If you're at the 'we think part of our platform is Class I' stage, start by showing us the product. Bring the relevant features, the claims you're making, the evidence you already have and the date you're working towards.
We'll start by scoping the assessment. Once the classification is established, we can agree the documentation and evidence work. Highguard provides managed healthcare compliance support, bringing policies, clinical safety work and supporting evidence together. You should know what needs doing before committing to the work.