If you search for a medical device technical file template you will mostly find tables of contents rather than anything you can actually use, so this post sets out the folder structure we create at the start of every project at MDIN. It follows Annex II and Annex III of the EU MDR and it works for UKCA marking too. Neither the UK nor the EU regulations mandate a particular layout. They only say what the documentation must contain and that it must be presented in a clear, organised, readily searchable and unambiguous manner, and a sensible folder tree agreed on day one is the cheapest way we know of meeting that requirement. If you want the detail of what each document should say, our guide to what goes in a medical device technical file covers the contents. This post is about where everything lives.
Why we structure the file around Annex II
Annex II of the EU MDR lists the technical documentation in a set order: device description and specification, information to be supplied by the manufacturer, design and manufacturing information, the general safety and performance requirements, the benefit-risk analysis and risk management, and product verification and validation. Annex III adds the post-market surveillance documentation. Reviewers at notified bodies assess files against that order, so a file arranged the same way gets reviewed faster and attracts fewer clarification questions, and every round of questions adds weeks before the device reaches the market.
The UK regulations (the Medical Devices Regulations 2002, as amended) are still based on the old directives, so they ask for broadly the same evidence under slightly different headings (essential requirements rather than GSPRs, for example). We build one file to the Annex II structure and handle the UK differences with a separate checklist rather than maintaining two parallel files, and I’ll come back to that below.
The technical file template, folder by folder
This is the tree we set up, numbered so it sorts correctly whatever system it sits in:
technical-file/
├── 00 Admin and declarations
│ ├── Declaration(s) of Conformity
│ ├── Certificates (approved or notified body, where applicable)
│ └── Registrations (MHRA, EUDAMED, UDI records)
├── 01 Device description and specification
│ ├── Intended purpose and claims
│ ├── Classification rationale
│ ├── Variants, sizes and accessories
│ └── Previous generations and similar devices
├── 02 Information supplied with the device
│ ├── Labels and packaging artwork
│ ├── Instructions for use (all language versions)
│ └── Patient-facing information, where applicable
├── 03 Design and manufacturing information
│ ├── Design drawings and specifications
│ ├── Materials and components
│ ├── Manufacturing process descriptions
│ └── Suppliers and manufacturing sites
├── 04 GSPRs and essential requirements
│ ├── GSPR checklist (EU MDR)
│ ├── Essential requirements checklist (UKCA)
│ └── Standards list with editions and dates
├── 05 Risk management
│ ├── Risk management plan
│ ├── Risk analysis
│ └── Risk management report
├── 06 Verification and validation
│ ├── Test plans and protocols
│ ├── Bench test reports
│ ├── Biocompatibility
│ ├── Sterilisation and shelf life (where applicable)
│ └── Usability
├── 07 Clinical evaluation
│ ├── Clinical evaluation plan
│ ├── Literature search protocol and report
│ └── Clinical evaluation report
├── 08 Post-market surveillance
│ ├── PMS plan
│ ├── PMS report or PSUR
│ └── Vigilance and complaint handling records
└── 09 Index and change control
├── Technical file index
└── Change logGet the folder template
You’re welcome to a copy of the technical file template as a zip of empty, numbered folders, with a one-page PDF of the structure.
Leave your details and we will email you the zip and the one-page PDF, and take you straight to the download page.
A few notes on the folders
Folder 00 holds the documents that prove status rather than safety, meaning the Declaration of Conformity and any certificates, along with the registration records. These are what an importer or a customs query will ask for first, and you don’t want to be hunting for them.
Folder 04 is the spine of the file. Each GSPR or essential requirement maps to a document elsewhere in the tree, so the checklist becomes the index a reviewer actually works from, and keeping the standards list in the same folder means the editions get updated whenever the checklist does.
Folder 06 tends to be the largest for the mechanical devices we work on. It’s where our own workshop output lands, the bench test reports from our force tester and the protocols and rig drawings behind them, and it’s worth filing the raw data alongside the reports because reviewers do occasionally ask for it.
Folder 08 matters more than it used to in Great Britain. The strengthened UK post-market surveillance requirements have applied since 16 June 2025 and they expect a documented PMS plan and periodic reporting even for a Class I device, so the folder should never be empty, not even on day one.
One file for both UKCA and CE marking
Most of the devices we work on are heading for the UK and Europe, so the practical question is how to serve both from one set of evidence. The test reports, risk management, clinical evaluation and design documentation are the same work either way, so we keep a single file in the structure above and put the route-specific documents in two places only: the two checklists in folder 04 and the separate Declarations of Conformity in folder 00. At the time of writing the GB acceptance dates for CE marked devices still stand (30 June 2028 for devices certified under the old directives and 30 June 2030 for EU MDR devices), and the consultation on recognising CE marking indefinitely closed in April 2026 without that change being confirmed for the forthcoming legislation, so it remains sensible to build the file so that a UKCA submission is a checklist exercise rather than a rewrite. If you’re weighing up which route to run first, our post on UKCA vs CE marking in 2026 goes through that decision.
Keeping the file under control
A technical file is a living set of documents. PMS findings feed back into risk management, and a design change ripples through the drawings and on into verification and the IFU. Standards get revised too. The structure only helps if the file keeps up with all of that.
The habits that keep it manageable are reasonably simple. Every document carries a document number plus its revision and date. The index in folder 09 lists them all with their revision status and the change log records what changed and why, and superseded revisions move to an archive rather than being deleted. We also keep working documents (CAD models and raw data, for example) separate from the issued PDF records. The file a reviewer sees should be the controlled PDFs, with the working files retrievable behind them. Reviewed once or twice a year, perhaps alongside your internal audit, a file in this shape stays submission-ready, which matters when an investor’s due diligence or an approved body application lands at short notice.
We build and maintain technical files as part of device development projects and as a standalone piece of work (there’s more on our technical file creation page), and we built the CE technical file for a powered nasal irrigator that is now with a notified body, so the template above is in live use rather than theory.
Frequently asked questions
No. Neither the UK regulations nor the EU MDR prescribes a folder structure or a template. They define the required content and say it must be clear, organised, readily searchable and unambiguous. The structure in this post follows the order of EU MDR Annex II and Annex III because that’s the order reviewers assess against.
Not in practice. The test evidence and the risk management file are the same whichever route you take, so one file with two conformity checklists and two Declarations of Conformity is the usual approach. The UK checklist is written against the essential requirements of the Medical Devices Regulations 2002 as amended, and the EU checklist against the MDR’s general safety and performance requirements.
Electronic, almost always. Notified bodies and approved bodies expect electronic submissions, and version control is far easier. We keep the issued records as controlled PDFs with the working files behind them.
Whenever the device or its claims change, and routinely when post-market surveillance findings come in. As a minimum, review the whole file once or twice a year, which pairs naturally with an internal audit cycle.
Yes. The manufacturer of a non-sterile, non-measuring Class I device self-declares conformity, but must still hold full technical documentation and make it available to the MHRA or a competent authority on request, and since June 2025 the UK PMS requirements apply to Class I devices too, so folder 08 is not optional.
If you’re starting a technical file, or you have one that’s grown organically and needs restructuring before a submission, I’d be happy to have a call to talk it through. You can book a free 30 minute slot here: https://calendly.com/mdin-uk/30min