UKCA technical file software

Build and maintain UKCA and CE technical documentation in one AI-assisted workspace, with specialist support when you need it.

To place a medical device on the market in Great Britain you need UKCA marking and the technical documentation behind it. Most manufacturers serving both markets also hold an EU MDR technical file. Obodux keeps both in one structured workspace, so shared evidence is written once and kept consistent.

It is built for small and mid-sized manufacturers selling into Great Britain, the EU, or both.

UKCA and CE in one workspace

Shared device record

Device description, intended purpose, variants and labelling held once and used for both markets.

Market-specific requirements

Mark each device for UKCA, CE or both, and keep market-specific content clearly separated.

Risk management (ISO 14971)

One risk management file supporting both technical files, kept consistent as the device changes.

Labelling

UKCA and CE labels and instructions for use, linked to the devices and markets they apply to.

Verification and clinical evidence

Test reports and clinical evaluation organised once and referenced wherever they are needed.

Post-market surveillance

PMS activity tracked in one place for both regulatory systems.

How it works

Bring in your documents
Upload your existing UKCA and CE documentation. Obodux organises it into a structured technical file.
See the gaps
Start with a free gap analysis of how your documents map to the Obodux structure.
Draft with AI assistance
Use guided templates and AI drafting to complete missing sections, with your team approving every change.
Get specialist review
Ask Obodux regulatory specialists to review the sections that matter most.

Who it is for

UK manufacturers placing devices on the Great Britain market
EU and international manufacturers selling into Great Britain
Teams maintaining an EU MDR technical file alongside UKCA

Common questions

Can one set of documents support both UKCA and CE?

Much of the evidence is shared, such as device description, risk management and test reports. Obodux holds it once and keeps market-specific content separate, so you are not maintaining two diverging copies.

Can CE marked devices still be sold in Great Britain?

The UK government has extended acceptance of CE marked devices in Great Britain for a transition period. Check the current MHRA guidance for your device, as the rules and dates can change.

Will Obodux guarantee UKCA marking?

No. Obodux is a documentation tool with optional specialist review and does not provide regulatory advice. Your organisation remains responsible for its technical documentation.

Build your UKCA technical file with Obodux

Start with a free gap analysis, or try Obodux free for 4 weeks.

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Obodux is a documentation tool from BORIS Software Ltd. It does not provide legal or regulatory advice and does not guarantee CE, UKCA or any other approval. AI suggestions are guidance only, and manufacturers remain responsible for their technical documentation. Further reading: UKCA technical documentation guide.

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Obodux is a SaaS platform that streamlines medical device compliance. Using AI tools and a secure workspace, it helps prepare CE, UKCA, and global documentation faster, stay audit-ready, and launch products confidently.

Compliance Disclaimer: Obodux provides tools to assist with regulatory compliance but does not guarantee regulatory approval. Users remain responsible for ensuring their compliance with applicable regulations.