A CE logo is not documentation.

Many clinics only discover missing documentation when authorities or insurance companies request it.

Compliance and documentation for aesthetic clinic equipment in Denmark

Compliance for aesthetic clinics is about more than a CE mark on the equipment. When a clinic uses laser equipment, IPL, RF equipment, microneedling or other energy-based equipment, the documentation must be correct, accessible and legally valid in Denmark and the EU.

For aesthetic clinic equipment, documentation typically includes a Declaration of Conformity (DoC), technical documentation, correct classification, and assessment of whether the equipment is covered by the EU's Medical Device Regulation (MDR). Not all aesthetic machines are subject to the MDR, but if the equipment falls within the scope of the regulation, specific requirements are imposed for documentation, risk assessment, and traceability.

In addition, the importer's responsibility must be assessed. If the equipment is imported from countries outside the EU, the importer has an independent legal responsibility for ensuring that the product complies with applicable EU legislation. This includes checking the CE marking, available documentation and correct labelling on the product. Clinics should therefore know who is actually the responsible economic operator in the EU.

Inadequate documentation can be important in connection with regulatory oversight, insurance cases or complaints about treatments. If the documentation cannot be provided, it can create legal and financial risk for the clinic. Therefore, CE documentation, MDR status and technical file should be assessed systematically and not based solely on verbal information from the supplier.

A compliance review of clinical equipment typically involves an assessment of:

  • Valid Declaration of Conformity
  • Compliance between product and documentation
  • Classification according to relevant EU legislation
  • Assessment of MDR relevance
  • Importer and distribution responsibility
  • Availability of technical documentation

The purpose is to create clarity about whether the clinic's equipment meets current requirements in Denmark and the EU, and whether the documentation is sufficient when requested by authorities or insurance companies.

  • CE documentation

    We assess whether the documentation is valid, correctly issued and available upon request.

  • MDR status

    Is the equipment correctly classified – and does the MDR apply in this specific case?

  • Importer responsibility

    Who bears legal responsibility in Denmark if documentation is requested?

We deliver responsibility – not just equipment.

Velurex is built on documentation before design.

Pre-marketing compliance.

Structure before sale.

We do not sell equipment that we cannot guarantee ourselves.