Biocompatibility · Skin safety
HRIPT and Skin Prick Test, the skin-safety evidence regulators expect.
For devices in prolonged skin contact, sensitisation and irritation data are not optional. Here is how HRIPT and the Skin Prick Test fit FDA and Notified Body expectations for aesthetic and dressing devices.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Skin-safety studies, run to the standard.
Sensitisation data is only useful if the study is designed correctly. Our teams run HRIPT and SPT the way reviewers read them.
Dr Mark DaCosta
Cardiac surgeon and former lead Notified Body reviewer at TÜV SÜD. 400+ devices CE-certified.
in LinkedIn
Charline Petitdemange
ISO 14155 study conduct, EUDAMED registration and multi-country site monitoring across Europe.
Awards, 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 →The tests
Two tests, one question: is it safe on skin?
For aesthetic devices and dressings, biocompatibility centres on skin sensitisation and irritation. HRIPT and the Skin Prick Test are the clinical tools that answer it.
01
Why skin-contact devices need this
Under both the FDA framework and EU MDR, a device in prolonged or repeated skin contact must demonstrate it does not cause sensitisation or unacceptable irritation. ISO 10993-1 sets the biological evaluation, and ISO 10993-10 governs irritation and skin sensitisation specifically. For aesthetic devices and dressings, human skin-safety data is often expected on top of the chemical and in-vitro assessment.
02
The Human Repeat Insult Patch Test
The HRIPT applies the device or its extract to the skin repeatedly over an induction phase, then, after a rest period, a challenge patch tests whether the immune system has been sensitised. It is the reference clinical test for contact sensitisation potential.
A clean HRIPT needs
- An adequate panel size for a meaningful negative claim
- A defined induction and challenge schedule
- Trained, blinded dermatological scoring
- Correct handling of the extract or finished device
03
The Skin Prick Test
The Skin Prick Test assesses immediate (IgE-mediated) hypersensitivity by introducing a small amount of the substance into the epidermis and reading the wheal-and-flare response. It complements HRIPT, which targets delayed (Type IV) sensitisation, so together they cover both mechanisms relevant to skin-contact devices.
04
Fitting it into the evidence package
Skin-safety testing does not stand alone: it feeds the biological evaluation and the Clinical Evaluation Report (CER). The winning approach is to plan HRIPT/SPT as part of the overall biocompatibility strategy, so a reviewer sees a coherent evaluation rather than a bolt-on study.
Skin safety at a glance
Both mechanisms, covered.
Talk to a specialist
Planning skin-safety testing for an aesthetic device or dressing?
Book a free scoping call. We design HRIPT and SPT studies that satisfy FDA and Notified Body expectations and feed your biological evaluation.
Book a free scoping callSkin-safety data a reviewer trusts starts with study design.
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