Glossary
Medical-device regulatory glossary.
Concise definitions and quick references for EU MDR, IVDR, FDA pathways, quality systems, risk management, post-market work, and regulatory documentation.
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510(k) - Premarket Notification 510(k) Special / Abbreviated Abbreviated New Drug Application (ANDA) Adverse Event Approved Supplier List (ASL) Audit Biocompatibility CE marking (CE mark) Clinical evaluation — MDR Article 61 & Annex XIV explained Clinical Evaluation Report (CER) Clinical Testing Combination Product Competent Authority (CA) Compliance Compliance Officer Conformity Assessment (CA) Corrective and Preventive Action (CAPA) Design Controls Device History Record (DHR) Device Identification Device Master Record Document Change Order (DCO) Drug Master File (DMF) Essential Principles EUDAMED (European Database on Medical Devices) FMEA (Failure Modes and Effects Analysis) Food and Drug Administration (FDA) General Safety and Performance Requirements (GSPR) — EU MDR Annex I explained Human Factors Engineering In Vitro Diagnostic (IVD) Device In Vitro Diagnostic Regulation (IVDR) Intended use Investigational Device Exemption (IDE) ISO 13485 ISO 14971 Labeling Legacy Medical Device Legal manufacturer Medical Device Medical Device Regulation (MDR) Medical Device Single Audit Program - MDSAP Nonconformance Report (NCR) Notified Body Person Responsible for Regulatory Compliance (PRRC) Post-Market Surveillance Premarket Approval (PMA) Premarket Notification - 510(k) Quality Management System Quality System Regulation (QSR) - QMSR Regulatory Affairs Regulatory Agency Regulatory Approval Regulatory Classification Regulatory Submission Reimbursement Risk Analysis Risk Management Single-use devices Software as a Medical Device (SaMD) Standard Operating Procedure Technical File (Technical Documentation) — EU MDR Annex II requirements Unique Device Identifier (UDI)
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