Aesthetic Devices Under EU MDR
Annex XVI, Section 5
"Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing."
Aesthetic medical devices such as dermal fillers fall under Annex XVI, Section 5. Even if marketed for aesthetic use only, they are still regulated under MDR.
Performance is defined not only by clinical safety and wrinkle reduction, but also by how patients feel about their results. That's why the Global Aesthetic Improvement Scale (GAIS) has become one of the most widely used tools in clinical studies and daily practice for dermal fillers, PRP, skin rejuvenation, and other aesthetic treatments.
Applicable EU MDR Articles
Article 1(2) MDR
Extends the regulation to Annex XVI products without an intended medical purpose (e.g., fillers, lipolysis devices, lasers for hair removal, etc.).
Article 1(6) MDR
Covers risk management, clinical evaluation, and post-market clinical follow-up (PMCF) requirements.
Article 61 MDR
Governs Clinical Evaluation.
GAIS for Aesthetics survey under EU MDR: Measuring Patient Satisfaction and Treatment Success
Aesthetic medical devices such us Dermal fillers fall under Annex XVI, Section 5: "Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing."
Even if marketed for aesthetic use only, they are still regulated under MDR.
Performance is defined not only by clinical safety and wrinkle reduction, but also by how patients feel about their results. That's why the Global Aesthetic Improvement Scale (GAIS) has become one of the most widely used tools in clinical studies and daily practice for dermal fillers, PRP, skin rejuvenation, and other aesthetic treatments.
Applicable EU MDR articless
Article 1(2) MDR
Extends the regulation to Annex XVI products without an intended medical purpose (e.g., fillers, lipolysis devices, lasers for hair removal, etc.).
Article 1(6) MDR
cover risk management, clinical evaluation, and post-market clinical follow-up (PMCF) requirements.
Article 61 MDR
Governs Clinical Evaluation.
What Is GAIS?
The Global Aesthetic Improvement Scale (GAIS) is a simple, validated assessment tool used to measure the overall aesthetic improvement of a patient after treatment.
It is typically scored on a 5-point ordinal scale, ranging from "Very Much Improved" to "Worse."
GAIS can be completed by both:
- Investigators (IGAIS): Clinician's perspective on the improvement.
- Patients (SGAIS): Patient's own perception of improvement.
👉 This dual perspective makes GAIS a powerful measure of treatment success and satisfaction.
GAIS Scoring System
The most common GAIS scale is as follows:
| Score | Definition |
|---|---|
| 5 | Very much improved |
| 4 | Much improved |
| 3 | Improved |
| 2 | No change |
| 1 | Worse |
This simple framework allows clinicians and patients to align expectations and outcomes in a standardized way.
Why GAIS survey Is Essential in Aesthetic PMCF activities
Patient-Centered Evidence
GAIS survey captures how patients feel about their results, a critical element in aesthetics where perceived improvement drives satisfaction.
Regulatory Acceptance
Notified Bodies and regulators under EU MDR increasingly expect PROs (Patient-Reported Outcomes) like GAIS to be included in PMCF (Post-Market Clinical Follow-up) studies.
Simplicity and Versatility
GAIS is easy to implement across a wide range of procedures:
- Dermal fillers (nasolabial folds, lips, cheeks)
- PRP and skin rejuvenation
- Energy-based devices (lasers, RF, ultrasound)
Complement to Other surveys
GAIS is often paired with validated scales such as:
- Wrinkle Severity Rating Scale (WSRS) for objective wrinkle depth
- FACE-Q for detailed patient-reported satisfaction
- EQ-5D-5L for quality of life measures
GAIS in Clinical Practice
In a typical filler or PRP study:
- Patients complete SGAIS at follow-up visits (Day 28, Day 84, Month 6).
- Investigators complete IGAIS using standardized photographs.
- Results are combined to provide a holistic view of treatment success.
This alignment strengthens the scientific validity and notified body acceptability.
Key Takeaway
The Global Aesthetic Improvement Scale (GAIS) is a simple yet powerful tool that bridges clinical outcomes with patient satisfaction. By integrating GAIS into both clinical studies and routine practice, manufacturers and physicians can demonstrate value, ensure compliance with MDR, and build stronger trust with patients.
👉 If you are planning a PMCF survey or clinical investigation for fillers, PRP, or aesthetic devices, combining GAIS with FACE-Q and WSRS provides a complete evidence package for both regulators and patients.
How MILO Makes FACE-Q Data Collection Easier
Collecting high-quality survey data can be logistically challenging. The MILO platform offer Survvey model for PMCF activitiers that digitizes FACE-Q, making studies easier to run:
ePRO/ Survey access on smartphone/tablet/PC.
Automated visit reminders.
ISO 14155 & GDPR compliance.
Real-time dashboards for investigators/sponsors.
Multilingual support for validated FACE-Q translations.
Integration with clinical outcomes and safety data.
👉 MILO turns FACE-Q into a seamless digital workflow, ensuring higher completion rates and regulatory-grade evidence.
Check out the testimonial from RegenLab, a leading Swiss company specializing in PRP manufacturing for aesthetic applications.
Testimonial:
Antoine Turzi
Chief Executive Officer of RegenLab
We are currently collaborating with ECLEVAR MEDTECH on five European studies, two in wound care and three in aesthetics. Their use of the MILO Studio platform to design and collect survey data has been a real asset. The system is intuitive, compliant, and delivers high-quality insights. Our key opinion leaders are very satisfied with the efficiency and reliability it brings to our projects.
Valérie de Fourmestraux, PhD
Regenlab
As Clinical Study Manager, I have been impressed by ECLEVAR MEDTECH's expertise in running complex aesthetic clinical studies. Their use of the MILO platform has transformed the way we manage patient-reported outcomes — making data collection seamless, compliant, and highly reliable. MILO gives our investigators and KOLs real-time visibility on study progress, which significantly improves both the quality of our research and the satisfaction of our clinical partners.
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