EU declaration of conformity · technical file · CE
We prepare the declaration of conformity for your product.
From identifying the applicable directives and harmonised standards, through risk assessment and the technical file, to a document ready for your signature. Machinery, electronics, appliances, medical devices and packaging.
When clients call us
Most people call in one of these six situations.
- A customer or retail chain asks for a declaration of conformity and you have none.
- A marketplace has blocked your listing over missing documentation.
- You are placing a new product on the market and need to know what must exist.
- The market surveillance authority has opened an inspection.
- You import from outside the EU and take on the manufacturer's obligations.
- You have a declaration but are not sure it would hold up.
What we do
One service and five things behind it
A declaration of conformity is not a form to fill in. It is the last page of a file that has to exist for the product — and we prepare that file too.
Declaration of conformity, tailored to the product
We identify which directives and regulations apply, compile the list of harmonised standards, prepare the risk assessment and the technical file — and on that basis we draft the EU declaration of conformity ready for signature. The manufacturer or importer signs it; our job is to make sure there is something solid behind that signature.
Deliverables
What you have in hand when we are done
- An EU declaration of conformity ready for signature, in Czech and English.
- A list of the harmonised standards applied, including editions and dates.
- A risk assessment describing the measures taken.
- A technical file organised so it can be handed to an inspector.
- Instructions on what to keep and for how long — usually ten years from placing on the market.
- Expert support whenever somebody questions the documentation.
How it works
Four steps from product description to signature
- 01
Consultation
Send us a product description, photos or a schematic. We will tell you what applies and what is missing. No obligation.
- 02
Legislation and standards
Which directives apply, which harmonised standards to use and whether a notified body is involved.
- 03
Supporting documents
Risk assessment, arranging tests where needed, and compiling the technical file.
- 04
Declaration
A document ready for signature and a file you can present to a customer or an inspector.
We adapt lead times to the client's needs and will give you ours at the first consultation. If an inspection is already underway, we treat it as a priority.
Why it matters
Compliance is decided during development.
When conformity is only addressed on a finished product, the fix often costs more than the development did. We can name the risks and the standards before the first prototypes exist.
- Identifying legislation — which directives and standards apply to the product.
- Risk assessment — what to change before the series is produced.
- Testing and documentation — only then does the declaration come into being.
Market surveillance
Inspection at your door? You are not on your own.
The Czech Trade Inspection Authority (ČOI) will ask for the technical documentation, the declaration of conformity and test evidence. We go through what exists for the product, supply what is missing and prepare an expert statement for dealing with the inspectors.
References
Companies we have prepared documentation for
A selection of the companies we work with on conformity assessment, documentation and testing. We are happy to pass on a contact for a specific reference on request.
- EU Factory
Contact
Working on a specific product?
Write a few sentences about the device — what it is, where it is sold and who manufactures it. We will come back with a proposed approach, a lead time and a price. The first consultation is free and commits you to nothing.
info@posouzenishody.cz
+420 776 337 083
Jaroslav Křepelka
managing director, DoC solutions s.r.o.
I have spent over fifteen years in product certification and testing, including life-support medical devices.
Our second project
Simple product? You can do it yourself.
At MyCECheck.com you can have an existing declaration reviewed against the legislation that actually applies to your product, or build a new one with a step-by-step guide. It makes sense for a product covered by a single clear directive that already has a technical file.
Free
EU legislation search
The full text of the CE-marking directives and regulations (LVD, EMC, RED, machinery, RoHS, GPSR, CRA and more) and the harmonised standards lists in one place. Find the exact article, and whether a standard is still cited.