Directive (EU) 2019/882 · Annex IV and Article 16
The technical file a covered product has to have behind it
A product in scope of the European Accessibility Act does not publish a statement the way a service does. It carries a technical file, a declaration of conformity and the CE marking, and the file is the part an authority asks for. It is also the part that most manufacturers assemble in a hurry, months after the product shipped.
Which products are in scope
The directive lists them: consumer general purpose computer hardware and operating systems, self-service terminals such as payment terminals, ATMs, ticketing and check-in machines, consumer terminal equipment with interactive computing used for electronic communications or for accessing audiovisual media services, and e-readers. If what you place on the market is on that list, the product regime applies whatever the size of your company.
What the file has to contain
| Section | What goes in it |
|---|---|
| Product description | What it is, what it does, the models and versions the file covers |
| Requirements applied | The accessibility requirements of Annex I that apply, requirement by requirement |
| Standards used | Harmonised standards or technical specifications applied, in full or in part, with the parts identified |
| Design and manufacture | Drawings, schemes and descriptions needed to understand how the product works |
| Solutions adopted | How each requirement is met, in the product rather than in the manual |
| Assessment | The results of the checks carried out, with the method |
| Disproportionate burden | If claimed, the assessment with the criteria of Annex VI and the figures behind it |
Internal production control, not a certificate
The conformity assessment for products under this directive is internal production control, Module A. You carry out the assessment, you keep the file, you draw up the EU declaration of conformity and you affix the CE marking. No notified body issues anything, which means there is no certificate to buy and nobody to blame if the file is thin.
Who keeps it, and for how long
The manufacturer keeps the file and the declaration for five years after the product was placed on the market. An importer keeps a copy of the declaration for the same period and makes sure the manufacturer has drawn up the technical documentation. A distributor has to check that the CE marking is there, that the documentation accompanies the product and that the manufacturer and importer have met their obligations. Where a distributor or importer markets the product under its own name, it takes on the manufacturer obligations, file included.
The disproportionate burden claim is not a shortcut
Article 14 allows a manufacturer to conclude that a requirement would impose a disproportionate burden, but only after an assessment based on the criteria in Annex VI, documented and kept for five years. The assessment compares the cost of the change with the size of the operation and the estimated benefit for persons with disabilities. A claim without those numbers is not an exemption, it is an admission.
What happens when an authority asks
The request comes with a deadline and asks for the file in a language the authority can understand. If the documentation does not show that the product meets the requirements, the authority can require corrective action, restrict availability, order withdrawal or recall. Formal non-compliance, missing CE marking, missing declaration, incomplete documentation, is treated as non-compliance in its own right, before anyone tests the product itself.
Where files usually fail
- They describe the product and skip the requirement-by-requirement mapping, which is the part that carries the argument.
- They cite a harmonised standard in full when only parts of it were applied, without saying which parts.
- They contain test results with no method and no date, so nobody can tell what was actually done.
- They claim disproportionate burden with a sentence instead of the Annex VI assessment.
- They cover one model and are then reused for a variant that changed the interface.
Placing on the market is a moment, and it fixes the file
The obligations attach when the product is first made available on the Union market, and the documentation has to describe that product as it was then. A later firmware release that changes the interface does not sit outside the file: it updates it. Keeping a dated history of those updates is what lets you answer a question about a unit sold three years ago without guessing.
The same moment decides who carries what. A manufacturer outside the Union sells through an importer, and that importer takes on real duties: check the assessment was done, keep the declaration, put its name on the product, and refuse to place it on the market if the documentation is missing. Importers who treat this as paperwork discover during an inspection that it was the obligation.
Products and services in the same company
A manufacturer that also runs a consumer app or a web shop has both regimes running at once: the file for the hardware, the published statement for the service. The underlying testing overlaps, the paperwork does not, and keeping them in one cycle is cheaper than discovering the second one later. See how the app side works and what enforcement looks like.
What we prepare
We test the product interface against the applicable requirements, write the requirement-by-requirement mapping, record the method and the results, and assemble the file in the structure Annex IV asks for, ready for your declaration of conformity. Where you claim disproportionate burden for a requirement, we document the assessment with the Annex VI criteria rather than asserting it. Product files are quoted after a first look at the product.
Questions we get before buying
Does a service provider need an Annex IV file?
No. Services publish a statement under Annex V. The technical file belongs to products.
Do we need a notified body?
No. The assessment is internal production control, so you carry it out and keep the file yourself.
How long do we keep the documentation?
Five years from the moment the product was placed on the market, along with the EU declaration of conformity.
We import a product made outside the EU. What do we owe?
You verify that the manufacturer drew up the technical documentation, keep a copy of the declaration for five years, and put your details on the product or its packaging.
We sell the product under our own brand. Does that change anything?
Yes. A distributor or importer marketing under its own name takes on the manufacturer obligations, including the file.
Is CE marking under this directive the same as other CE marking?
The marking is the same symbol, the obligations come from each directive that applies. Accessibility adds its own assessment and its own documentation.
Can we claim disproportionate burden?
Only with the assessment set out in Annex VI, documented, with the figures. It is reassessed when the product changes or when the situation changes.
What if the authority asks in a language we do not use?
The file has to be available in a language the authority can understand. Plan for translation rather than argue about it under a deadline.
Does a software update change the file?
If it changes the interface or how a requirement is met, yes. The file describes what is on the market now.
How long does it take to prepare?
Quoted after a first look. A single terminal with one interface is quick; a family of models with variants takes longer, because each variant has to be mapped.
Get the file built before the request arrives
Requirement-by-requirement mapping, tested interface, recorded method and results, in the Annex IV structure.