A product that does not meet European regulation does not sell in Europe. Full stop.
It does not matter how good the device is or how competitive the price: if it does not comply, customs stops it, the distributor will not take it and the buyer will not sign. We find out what Europe demands of your product before you commit production, not after.
A wireless temperature logger is three things at once.
It is a measuring instrument, a piece of radio equipment and a product with digital elements. Three separate regulatory frames, and all three apply even if the factory is ten thousand kilometres away.
- As a measuring instrument: for quick-frozen food, Regulation (EC) No 37/2005 requires air temperature to be recorded with instruments conforming to EN 12830. In Spain, Order ITC/3701/2006 additionally places those recorders and thermometers under State metrological control.
- As radio equipment: Delegated Regulation (EU) 2022/30 has been mandatory since 1 August 2025. The EN 18031 harmonised standards are the route to presumption of conformity.
- As a product with digital elements: since 11 September 2026, the Cyber Resilience Act requires actively exploited vulnerabilities and severe incidents to be reported: early warning within 24 hours, full notification within 72, final report afterwards.
- And one question that always comes: if the device uploads readings to a cloud, the European buyer will ask which jurisdiction hosts them. Having an answer — and EU hosting — stops being a technical detail and becomes a sales argument.
This is general information about the applicable rules, not legal advice. Your specific product may carry additional requirements depending on its end use.
Four steps, no surprises at the end.
Classification
We determine which directives and regulations apply to your product by category, end use and any radio or connectivity functions.
Review of what you have
We read your current technical documentation, test reports and declarations. There is almost always something, and it is almost never complete.
Gap list
You get exactly what is missing: tests, harmonised standards, technical file contents, marking and instructions.
Closing the gaps
We stay with the manufacturer through the corrections and, where the product requires it, coordinate with the notified body.
A report you can act on, not a generic opinion.
What people ask
How do I know which regulation applies to my product?
You do not need to know in advance: classifying it is the first step of the service. The datasheet, the intended use and whether it carries radio or connectivity are enough to start.
The CRA applied from 11 September 2026. Does it reach me if I manufacture outside the EU?
Yes. The obligations are triggered by placing the product on the Union market, not by where it is made. Reports go through the CRA single reporting platform, which routes them to the national CSIRT and ENISA.
Does this replace CE marking?
No: CE marking is one of the pieces, and it has its own page. This service is the full map of what your product needs, of which CE is usually the most visible part.
And if the product does not comply today?
We tell you what has to change — materials, design, firmware or documentation — and the rough cost and lead time of each change. Sometimes the honest conclusion is that this particular model is not worth adapting, and we will say that too.