§ GLOSSARY

Medical Device Regulatory Glossary

100+ key terms and definitions for medical device regulatory professionals.

REGULATORY PATHWAYS

510(k) Clearance Premarket Approval (PMA)De Novo Classification CE Marking EU MDR (Regulation 2017/745)Medical Device Directive (MDD)Notified Body EUDAMED Shonin (Japan Pre-Market Approval)Ninsho (Japan Third-Party Certification)Breakthrough Device Designation Humanitarian Device Exemption (HDE)Conformity Assessment Authorized Representative IVDR (Regulation 2017/746)Marketing Authorization Holder (MAH)

QUALITY SYSTEMS

Quality Management System (QMS)Corrective and Preventive Action (CAPA)Design Controls Good Manufacturing Practice (GMP)Risk Management Sterilization Validation Shelf Life Korean Good Manufacturing Practice (KGMP)

STANDARDS

ISO 13485 ISO 14971 (Risk Management)IEC 62304 (Medical Device Software)ISO 10993 (Biocompatibility)IEC 60601 (Electrical Safety)

SAFETY SURVEILLANCE

Medical Device Recall MAUDE Database Adverse Event Vigilance Post-Market Surveillance (PMS)Field Safety Corrective Action (FSCA)MedWatch Periodic Safety Update Report (PSUR)Serious Adverse Event Device Deficiency

CLASSIFICATION

Class I Medical Device Class II Medical Device Class III Medical Device Predicate Device Substantial Equivalence Software as a Medical Device (SaMD)Combination Product Custom-Made Device Class IIa (EU MDR)Class IIb (EU MDR)Classification Rule AI/ML-Based Medical Device

CLINICAL

Clinical Evaluation Post-Market Clinical Follow-up (PMCF)Biocompatibility Clinical Investigation Investigational Device

DOCUMENTATION

Unique Device Identification (UDI)Technical Documentation General Safety and Performance Requirements (GSPR)Design History File (DHF)Device History Record (DHR)Device Master Record (DMR)Medical Device Labeling Instructions for Use (IFU)Summary of Safety and Clinical Performance (SSCP)Single Registration Number (SRN)Declaration of Conformity (DoC)GUDID (Global UDI Database)

ORGANIZATIONS

IMDRF MDSAP GHTF (Global Harmonization Task Force)