Technical Dossier – Requirements and Contents
A technical dossier is the complete documentation that forms the basis for a product's CE marking. For professional clinical equipment, this is a key part of regulatory compliance.
Without a correct technical dossier, the product may not be marketed in the EU.
What does a technical dossier contain?
The content depends on the product classification and relevant legislation, but can typically include:
• Product description
• Design and construction information
• Risk assessment
• Test results
• Standard references
• Instructions for use
• Traceability
The dossier forms the basis for the EU Declaration of Conformity.
Read about the EU Declaration of Conformity here:
https://velurex.dk/pages/eu-declaration-of-conformity
When is a technical dossier relevant?
Technical dossier is relevant for:
• CE marking
• MDR classification
• Imports to the EU
• Marketing in the EU
Read about CE and MDR here:
https://velurex.dk/pages/ce-og-mdr
Laser equipment and technical documentation
Professional lasers, including class 4 systems, require documented risk assessment and safety baselines.
Read about class 4 here:
https://velurex.dk/pages/laser-klasse-4
Read about safety here:
https://velurex.dk/pages/class-4-laser-safety
The role of the clinic
The clinic does not have to prepare a technical dossier itself, but should:
• Ensure that documentation exists
• Review relevant material
• Keep necessary documents
• Understand the supplier's role
Read about purchasing laser equipment here:
https://velurex.dk/pages/koeb-laserudstyr-til-klinik
Read about imports here:
https://velurex.dk/pages/import-af-medicinal-udstyr
Supplier's responsibility
A professional supplier must be able to account for:
• Existence of the dossier
• What legislation does the product fall under?
• What standards are used?
Read about supplier selection here:
https://velurex.dk/pages/laser-leverandoer-danmark
Contact
If you would like to discuss documentation and regulatory matters regarding clinical equipment, you can contact us here:
https://velurex.dk/kontakt