Regulations &
Certification
Every device we sell meets European safety and quality standards. Here is what that means for you.
CE Marking & EU MDR Compliance
The CE mark indicates that a product has been assessed and meets EU safety, health, and environmental protection requirements. For medical devices, this is governed by the EU Medical Device Regulation (MDR 2017/745), which became fully applicable in May 2021.
CE Marking
The CE mark on our devices confirms conformity with all applicable EU directives and regulations. It is a prerequisite for placing the product on the European market and signals that it is safe for its intended use.
EU MDR 2017/745
Medical devices in our range comply with the EU Medical Device Regulation. This covers clinical evaluation, risk management, post-market surveillance and technical documentation requirements.
ISO 13485 Quality Management
Our manufacturing partners hold ISO 13485 certification, demonstrating a quality management system specifically designed for medical device production — from design controls through to distribution.
Electrical Safety — IEC 60601-1
All electrical medical equipment in our range conforms to IEC 60601-1, the international standard for the basic safety and essential performance of medical electrical equipment.
Laser Safety Standards
Lasers used in aesthetic and medical applications are regulated under both EU machinery directives and international laser safety standards. All laser devices we supply are classified and labelled correctly.
EN 60825-1 / IEC 60825-1
Defines laser product safety requirements and establishes the classification system (Class 1–4). Our professional aesthetic laser systems are Class 4 devices, requiring trained operators and appropriate safety protocols.
- Mandatory safety labelling
- Beam hazard analysis documentation
- Nominal Ocular Hazard Distance (NOHD) specifications
Operator Requirements
Use of Class 3B and Class 4 laser systems in a professional setting requires trained and competent operators. Requirements vary by country:
- Belgium: Licensed medical or paramedical professionals
- Netherlands: BIG-register certified practitioners
- Germany: Medical professionals (Heilpraktikergesetz)
- France: Decree No. 2011-95 compliance required
Documentation & Traceability
We maintain full traceability for every device we sell. As the direct importer, we hold complete technical files and Declaration of Conformity documents for each product in our range.
Declaration of Conformity
A Declaration of Conformity (DoC) is available for each device. This document confirms which EU directives and standards the product complies with and is signed by the manufacturer's authorised representative.
Technical File
Full technical documentation — including risk assessments, design specifications, clinical evaluation reports, and test results — is maintained by the manufacturer and available to notified bodies upon request.
Post-Market Surveillance
We operate a post-market surveillance system as required under MDR. All serious incidents or near-misses involving our devices must be reported to the relevant national competent authority (e.g. FAMHP in Belgium, IGJ in the Netherlands).
Unique Device Identification (UDI)
Devices covered under EU MDR carry a Unique Device Identification code, enabling full traceability from manufacturer to end user. UDI information is registered in the EUDAMED database.
Request certification documents
Need a Declaration of Conformity or technical specification sheet for a specific device? Contact our compliance team.
Request documents →