Health regulation, defined.
Plain-language definitions of the EU and US health regulations HealthSignal tracks, from the MDR and IVDR to the AI Act, EHDS, DiGA, and health technology assessment. Each entry links to the live updates we monitor on that topic.
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CE Marking and Notified Bodies
CE marking is the conformity marking that shows a medical device meets EU legal requirements; notified bodies are the independent organisations that assess conformity.
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CTR (Clinical Trials Regulation)
The EU Clinical Trials Regulation (EU) No 536/2014 harmonises the authorisation and oversight of clinical trials across the EU through a single portal.
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DiGA (Digital Health Applications)
A DiGA is a digital health application that can be prescribed and reimbursed by statutory health insurance in Germany.
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EHDS (European Health Data Space)
The European Health Data Space is an EU framework for the primary and secondary use of health data across member states.
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EU AI Act
The EU AI Act, Regulation (EU) 2024/1689, is the EU's risk-based law on artificial intelligence; many medical AI systems are classified as high risk.
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GDPR in Healthcare
Under the GDPR, health data is a special category of personal data subject to stricter conditions for lawful processing.
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HTA (Health Technology Assessment)
Health Technology Assessment evaluates the clinical and economic value of health technologies to inform reimbursement and coverage decisions.
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IVDR (In Vitro Diagnostic Regulation)
The EU In Vitro Diagnostic Regulation (EU) 2017/746, governing the safety and market access of in vitro diagnostic medical devices.
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MDR (Medical Device Regulation)
The EU Medical Device Regulation (EU) 2017/745, the framework governing the safety and market access of medical devices in the European Union.
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Pharmacovigilance
Pharmacovigilance is the science and activity of detecting, assessing, and preventing adverse effects and other problems related to medicines.
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SaMD (Software as a Medical Device)
Software as a Medical Device is software intended for a medical purpose that performs that purpose without being part of a hardware device.