CE and MDR – What is the Difference?
The terms CE and MDR are often used interchangeably, but they do not mean the same thing. For clinics investing in energy-based equipment, it is important to understand the difference.
CE marking is a declaration.
The MDR is a regulation.
What is CE marking?
CE marking means that the manufacturer declares that the product complies with applicable EU legislation.
This typically involves:
• EU Declaration of Conformity
• Technical documentation
• Risk assessment
• Compliance with relevant directives or regulations
Read more about CE here:
https://velurex.dk/pages/ce-og-mdr
What is MDR?
MDR stands for Medical Device Regulation (EU 2017/745).
The MDR applies to products that are classified as medical devices. If a product falls under the MDR, more extensive requirements are placed on:
• Clinical evaluation
• Technical documentation
• Post-market surveillance
• Traceability
• Possible involvement of notified body
Therefore, not all CE marked products are covered by the MDR.
Are all aesthetic devices covered by the MDR?
No.
Some products may be CE marked under other directives, e.g.:
• Low Voltage Directive
• EMC Directive
Laser equipment is also classified according to safety standards and can be class 4 according to IEC 60825-1.
Read about class 4 here:
https://velurex.dk/pages/laser-klasse-4
Read about safety here:
https://velurex.dk/pages/class-4-laser-safety
What should clinics be aware of?
When purchasing equipment, you should clarify:
• Is the product covered by the MDR?
• What classification does it have?
• What documentation is available?
• What is 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 explain the difference between CE and MDR and review the documentation without ambiguity.
Read about the laser supplier here:
https://velurex.dk/pages/laser-leverandoer-danmark
Contact
If you would like to discuss CE, MDR and regulatory matters, you can contact us here:
https://velurex.dk/kontakt