Legal basis
Dioscope is positioned outside the scope of EU Regulation 2017/745 on medical devices (MDR) on the following basis:
Recital 19, MDR (EU) 2017/745
Software intended for non-medical purposes — including software intended for general purposes when used in a healthcare setting, lifestyle software and well-being software — is not a medical device. Dioscope falls within this scope as an educational and training platform.
Art. 2(1), MDR (EU) 2017/745
A medical device requires a specific medical purpose intended by the manufacturer for individual patients. Dioscope’s intended purpose is education and reference for healthcare professionals, not diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease in identified patients.
MDCG 2019-11 (Guidance on qualification of software)
Software whose intended purpose is education, training, reference or general well-being — even when used by healthcare professionals — is not qualified as a medical device. Dioscope’s outputs are reference summaries of authoritative published sources, intended for study and continuing professional development.
User responsibility
All clinical decisions remain the exclusive responsibility of the qualified healthcare professional. Any clinical action must be based on direct consultation of authoritative sources (Infarmed, EMA, official clinical guidelines) and on the professional’s own clinical judgement applied to the specific patient. Dioscope outputs must not be relied upon as the sole or primary source for any clinical decision.
Contact
For questions about intended use, regulatory positioning or compliance: suporte@dioscope.com.