Biocompatibility · Skin devices
Skin-safety testing for skin-contact devices, FDA and EU, without the guesswork.
When does a skin-contact device actually need human testing, and how do FDA and EU MDR differ? A clear route through HRIPT, the Skin Prick Test and the ISO 10993 biological evaluation.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
One skin-safety file, two markets.
FDA and EU expectations overlap but are not identical. We build a file that clears both.
Charline Petitdemange
ISO 14155 study conduct, EUDAMED registration and multi-country site monitoring across Europe.
Dr Mark DaCosta
Cardiac surgeon and former lead Notified Body reviewer at TÜV SÜD. 400+ devices CE-certified.
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 →The route
When human testing is actually required.
Not every skin-contact device needs a human study. The trigger is the biological evaluation: what the chemistry and in-vitro data leave unresolved is what human testing must close.
01
Start from the biological evaluation
ISO 10993-1 requires a risk-based biological evaluation before any test is chosen. For skin-contact devices the endpoints of interest are irritation and sensitisation (ISO 10993-10). Chemical characterisation and in-vitro assays come first; human testing such as HRIPT is used when residual risk on those endpoints cannot be resolved on paper.
02
Where FDA and EU align, and differ
Both the FDA and EU Notified Bodies work from the ISO 10993 series, so the science is shared. The differences are procedural.
What to watch
- FDA reviews biocompatibility within the 510(k) or PMA submission
- EU Notified Bodies assess it inside the technical documentation and CER
- Justifying use of existing data versus new testing differs in emphasis
- Both expect the evaluation, not just the raw test result
03
HRIPT and the Skin Prick Test
HRIPT tests delayed contact sensitisation through repeated induction and a later challenge; the Skin Prick Test assesses immediate hypersensitivity via the wheal-and-flare response. Choosing between, or combining, them depends on the material and the plausible mechanism of reaction, and both need adequate panels and blinded scoring to support a negative claim. For an aesthetic and dressing angle, see our companion HRIPT guide for aesthetic and dressing devices.
04
Building a defensible file
The failure mode is a study run without a clear question, producing data a reviewer cannot place. We tie every skin-safety test to a specific residual risk in the biological evaluation, so the file reads as a coherent argument on both sides of the Atlantic.
Skin devices at a glance
Evidence, not just a test.
Talk to a specialist
Not sure whether your skin-contact device needs human testing?
Book a free scoping call. We run the biological evaluation logic and tell you exactly what skin-safety data FDA and EU reviewers will expect.
Book a free scoping callThe skin-safety question is decided before the test, not after.
An expert read runs the biological evaluation, tells you if human testing is needed, and designs HRIPT or SPT that satisfies both FDA and EU reviewers.
Book a free scoping callQuestions we hear first