Import of Medical Equipment – Requirements and Documentation
Importing medical and aesthetic equipment into Denmark requires more than just delivery and installation. When equipment is brought into the EU market, there are clear requirements for documentation, CE marking and compliance with the MDR (Medical Device Regulation).
Clinics and suppliers have a shared responsibility to ensure that the equipment complies with applicable regulations.
When is equipment considered medical?
A product may be subject to medical regulation if it:
• Has a medical purpose
• Affects physiological functions
• Used for treatment or prevention
Laser equipment and certain energy-based systems often fall under regulation.
Read about class 4 laser requirements here:
https://velurex.dk/pages/compliance-class-4-laser-krav
CE marking upon import
Before equipment is placed on the market or put into use in the EU, it must be properly CE marked.
This involves:
• EU Declaration of Conformity
• Technical documentation
• Classification
• Risk assessment
• Traceability
Read more about CE and MDR here:
https://velurex.dk/pages/ce-og-mdr
Who is responsible?
When importing, there can be several roles:
• Manufacturer
• Authorized representative
• Importer
• Distributor
• Clinic
If a clinic itself imports equipment directly from a third country, it may in certain cases assume greater regulatory responsibility.
Read about the clinic's responsibilities here:
https://velurex.dk/pages/klinikkens-ansvar
Risks of inadequate documentation
Missing or insufficient documentation can lead to:
• Injunctions during inspection
• Equipment removal requirements
• Legal responsibility
• Economic loss
Regulatory transparency should therefore be a central part of the investment decision.
Connection with technology choices
Technology and documentation are closely related. When investing in, for example, a diode laser or picosecond laser, documentation should always be reviewed before purchase.
See professional diode laser here:
https://velurex.dk/produkter/diode-laser-808nm-1800w desktop model
Read about picosecond laser here:
https://velurex.dk/pages/picosecond-laser-klinik
Contact
If you would like to discuss documentation or regulatory matters when purchasing clinical equipment, you can contact us here:
https://velurex.dk/kontakt