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PubMed

Patient-tailored brachytherapy applicator development in compliance with the EU medical device regulation.

PMID: 41967338 · 2026

JournalPhysica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB)
Year2026
PMID41967338

Abstract

Clinical introduction of in-house developed medical devices in Europe requires conformity to the Medical Device Regulation (MDR) 2017/745 Article 5(5). Published experience on regulatory aspects of these devices is limited. This work describes our in-house development and verifications of the 3D printed patient-tailored ARCHITECT brachytherapy applicator and accompanying software, prepared to support clinical investigation and in-house use. Article 5(5) mandates an 'appropriate' quality manageme

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