CE Marked Laser Machine – What Do You Need to Know?

A CE marked laser machine means that the manufacturer declares that the product complies with applicable EU legislation. However, this does not automatically mean that all CE marked lasers are the same.

For clinics, it is important to understand what the CE marking covers – and what it does not cover.

What does CE marking entail?

CE marking is based on:

• EU Declaration of Conformity
• Technical documentation
• Risk assessment
• Compliance with relevant directives or regulations

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

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

Class 4 and CE

Many professional lasers are classified as Class 4. The classification is about safety level and is not the same as CE marking.

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

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

Are all CE marked lasers the same?

No.

There may be a difference between:

• Quality of documentation
• Test basis
• Classification
• Supplier's regulatory insight
• Support structure

Therefore, clinics should always review the documentation before purchasing.

Read about documentation when purchasing here:
https://velurex.dk/pages/dokumentation-ved-koeb-af-klinikudstyr

Import and responsibility

If a clinic itself imports a CE-marked laser machine from a third country, it may have a greater regulatory role.

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

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

See professional laser machine

See professional 808 nm diode laser here:
https://velurex.dk/produkter/diode-laser-808nm-1600w

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

Contact

If you would like to discuss CE-marked laser machines and documentation, you can contact us here:
https://velurex.dk/kontakt