Technology guide
Certifications and standards for aesthetic devices
CE marking, ISO 13485, IEC standards: what these labels mean and how to check a device's compliance before buying it.
Why it matters
Certifications and standards govern the safety and quality of devices. For a professional, they determine whether the device is legal, the safety of clients and often public liability insurance.
CE marking
In Europe, medical devices must comply with Regulation (EU) 2017/745, which replaced Directive 93/42/EEC. CE marking means that the manufacturer has demonstrated this compliance, with the involvement of a notified body for higher risk classes. Some aesthetic devices with no medical purpose also fall under this regulation, according to specific rules.
ISO 13485
This standard certifies the manufacturer's quality management system: control of manufacturing, inspections, traceability. It does not certify a device or its effectiveness, but it is a sign of reliability.
IEC standards and risk management
IEC 60601-1 covers the electrical safety of medical devices, IEC 60825-1 covers laser safety and classification, and ISO 14971 covers risk management. The corresponding test reports form part of the technical documentation.
How to check a device
Look for the CE marking and, where applicable, the notified body's number. Ask for the declaration of conformity, the valid ISO 13485 certificate and the test reports. Consult the European EUDAMED database. Look for clinical publications on the technology. If in doubt, ask an independent expert for advice.
What a certification does not tell you
CE marking and standards relate to safety and compliance. Clinical effectiveness is demonstrated by studies, ideally published and independent.