Short answer
An EU technical file contains the documents that prove a product complies with the applicable EU legislation. ISOCONSULT S.R.L. reviews what you already have, fills the gaps and organises the file in six standard components so it can be handed to any EU market surveillance authority on request.
The six components we check and complete
- General description and design documents: drawings, circuit or mechanical diagrams and the list of critical components
- EU Declaration of Conformity: drafted in English and Romanian, with the correct legislation and harmonised standards
- Test reports: from ISO/IEC 17025 accredited laboratories, checked for scope, standard versions and the tested model
- Risk assessment: intended use, foreseeable misuse and how essential health and safety requirements are met
- Instructions and safety information: user manual, warnings and technical data sheets in Romanian and the languages of your target markets
- Label and CE marking: artwork with CE marking, manufacturer data, our EU representative data and batch or serial identification
When documents are missing
If test reports are missing, incomplete or based on outdated standards, we coordinate testing with an accredited laboratory. Laboratory costs are passed on at cost. If your Declaration of Conformity is incorrect, we redraft it according to the model structure in Annex III of Decision 768/2008/EC.
Deliverables
- Gap report listing what is compliant, what is missing and what must change
- Corrected or new EU Declaration of Conformity (EN + RO)
- Risk assessment document
- Reviewed instructions and warnings
- Approved label artwork
- Indexed digital technical file, archived securely
Frequently asked questions
How much does a technical file cost?
The one-off setup fee is 600 to 1,500 EUR per product family, depending on technical complexity. A simple accessory sits at the lower end; electronic equipment covered by several directives sits at the higher end.
Do you send our technical file to the authorities proactively?
No. The technical file is not registered anywhere in advance. We keep it and provide it when a competent authority makes a reasoned request.