Aesthetics · Annex XVI · PMCF
GAIS: proving aesthetic outcomes that pass EU MDR review.
Under EU MDR, aesthetic devices are judged on how patients feel about their results, not just safety. The Global Aesthetic Improvement Scale turns that perception into evidence a Notified Body will accept.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Aesthetic evidence, written and reviewed by clinicians.
Annex XVI programmes are run by people who have designed the studies and reviewed the submissions, not handed to a junior account team.
Dr Mark DaCosta
Former lead Notified Body reviewer at TÜV SÜD. 400+ devices CE-certified across specialties.
in LinkedIn
Pierre-Marie Boutanquoi
CERs and PMCF plans under EU MDR and MEDDEV 2.7/1 Rev 4, including patient-reported outcome strategy.
in LinkedInAwards, funding, accountability
Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →Where GAIS fits
Aesthetic devices under EU MDR.
Aesthetic medical devices such as dermal fillers fall under Annex XVI, Section 5: substances or items used for facial or other dermal or mucous membrane filling by injection or other introduction, excluding tattooing. Even when marketed for aesthetic use only, they are fully regulated under EU MDR.
The instrument
From the aesthetic outcome to the right evidence.
Performance in aesthetics is defined not only by clinical safety and wrinkle reduction, but by how patients feel about their results. GAIS turns that perception into a standardised, validated measure.
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What is GAIS?
The Global Aesthetic Improvement Scale (GAIS) is a simple, validated tool that measures a patient’s overall aesthetic improvement after treatment. It is scored on a 5-point ordinal scale and can be completed from two perspectives, which is what makes it so powerful: IGAIS (the investigator’s clinical view) and SGAIS (the patient’s own perception). Together they capture both treatment success and satisfaction.
| Score | Definition |
|---|---|
| 5 | Very much improved |
| 4 | Much improved |
| 3 | Improved |
| 2 | No change |
| 1 | Worse |
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Why GAIS is essential in aesthetic PMCF
For Annex XVI devices, Notified Bodies and regulators increasingly expect patient-reported outcomes (PROs) inside your Post-Market Clinical Follow-up. GAIS answers that expectation directly.
What GAIS delivers
- Patient-centred evidence: how patients actually feel about their results, the core driver of satisfaction in aesthetics
- Regulatory acceptance: a recognised PRO that reviewers accept in PMCF studies
- Simplicity and versatility: usable across dermal fillers, PRP, skin rejuvenation and energy-based devices (laser, RF, ultrasound)
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GAIS in clinical practice
In a typical filler or PRP study, patients complete SGAIS at follow-up visits (for example Day 28, Day 84, Month 6), while investigators complete IGAIS using standardised photographs. Combining the two gives a holistic view of treatment success and strengthens scientific validity and Notified Body acceptability.
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Stronger paired with other validated scales
GAIS is most robust as part of an evidence package rather than in isolation. We combine it with instruments matched to your claim and device.
Complementary instruments
- WSRS (Wrinkle Severity Rating Scale) for objective wrinkle depth
- FACE-Q for detailed patient-reported satisfaction — see our FACE-Q survey guide
- EQ-5D-5L for quality-of-life measures
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The evidence package that survives review
Combining GAIS with FACE-Q and WSRS gives a complete evidence package for both regulators and patients: perceived improvement, objective change, and satisfaction, all on validated instruments. That is what lets manufacturers demonstrate value, stay compliant with MDR, and build trust.
Proof, not adjectives
The numbers behind our aesthetic programmes.
Milo Studio for surveys
GAIS and FACE-Q as a seamless digital workflow.
Collecting high-quality survey data is logistically hard. The Milo Studio Survey module digitises GAIS, FACE-Q and WSRS so studies are easier to run and completion rates stay high.
Milo Studio · Survey module
Regulatory-grade PRO collection, out of the box.
Talk to a reviewer
Planning a PMCF survey for fillers, PRP or aesthetic devices?
Book a free strategy call. We help you choose the right combination of GAIS, FACE-Q and WSRS, and design a survey a Notified Body accepts on the first audit.
Book a free strategy callClient testimonial
Trusted for complex aesthetic studies.
RegenLab · PRP for aesthetics & wound care · 5 EU studies
A leading Swiss PRP manufacturer on running aesthetic studies with Eclevar and Milo Studio.
“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.”Antoine Turzi, CEO, RegenLab
“As Clinical Study Manager, I have been impressed by Eclevar’s expertise in running complex aesthetic clinical studies. Milo has transformed the way we manage patient-reported outcomes — making data collection seamless, compliant, and highly reliable, with real-time visibility for our investigators and KOLs.”Valérie de Fourmestraux, PhD · Clinical Study Manager, RegenLab
Turn aesthetic outcomes into evidence a Notified Body accepts.
An expert read tells you which PROs your Annex XVI device needs, how to combine GAIS with FACE-Q and WSRS, and how to build a PMCF survey that holds up at audit.
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