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CATÉGORIE: CLASSIFICATION
Dispositif sur mesure
Un dispositif fabriqué spécifiquement selon une prescription écrite d'un praticien qualifié pour un patient spécifique.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Custom-made devices are manufactured for a specific patient based on a written prescription from a qualified professional (definitions differ under EU MDR vs FDA custom device exemption). Rules are narrow and often misunderstood.
PROCESS / STEPS
- Confirm the legal definition in the target market (do not assume “patient-specific” equals custom-made).
- Document prescription, design adaptation, and manufacturing controls.
- Apply labeling and documentation duties; mass-produced patient-matched devices may still need full conformity assessment.
- Avoid using custom pathways to bypass clinical evidence for scalable products.
EXAMPLES
- A patient-matched orthopedic implant produced from a standard validated design workflow may still be a fully regulated device, not “custom-made.”
RELATED GUIDES & TOOLS
SOURCES
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