Documentation when purchasing clinical equipment

When purchasing professional clinic equipment, documentation is essential. Regardless of whether it is a laser, EMS or other energy-based system, proper documentation must be available before use.

Documentation reduces regulatory risk and ensures transparency.

What documents should you require?

When purchasing clinic equipment, you should at least be able to show:

• EU Declaration of Conformity
• Information on applicable directives or regulations
• Instructions for use
• Information about classification
• Traceability information

Read about the EU Declaration of Conformity here:
https://velurex.dk/pages/eu-declaration-of-conformity

CE and legal basis

CE marking can be based on different legal bases depending on the product's classification.

Read about CE and MDR here:
https://velurex.dk/pages/ce-og-mdr

Technical dossier

The technical dossier forms the basis for the CE marking.

The clinic should not have full access to the entire dossier, but should be able to confirm that it exists and has been prepared correctly.

Read about the technical dossier here:
https://velurex.dk/pages/teknisk-dossier

Class 4 and safety

For laser equipment, the classification should be clear.

Read about class 4 here:
https://velurex.dk/pages/laser-klasse-4

Read about safety here:
https://velurex.dk/pages/class-4-laser-safety

Import and responsibility

With direct import, the clinic itself can have a greater regulatory role.

Read about importing equipment here:
https://velurex.dk/pages/import-af-medicinal-udstyr

Read about the clinic's responsibilities here:
https://velurex.dk/pages/klinikkens-ansvar

Signs of inadequate documentation

Be careful if:

• Documentation cannot be presented
• CE marking cannot be documented
• The supplier avoids concrete answers
• Classification is unclear

Read about purchasing laser equipment here:
https://velurex.dk/pages/koeb-laserudstyr-til-klinik

Contact

If you would like to discuss documentation and regulatory matters when purchasing clinical equipment, you can contact us here:
https://velurex.dk/kontakt