§ GLOSSARY
Medical Device Regulatory Glossary
100+ key terms and definitions for medical device regulatory professionals.
REGULATORY PATHWAYS
510(k) ClearancePremarket Approval (PMA)De Novo ClassificationCE MarkingEU MDR (Regulation 2017/745)Medical Device Directive (MDD)Notified BodyEUDAMEDShonin (Japan Pre-Market Approval)Ninsho (Japan Third-Party Certification)Breakthrough Device DesignationHumanitarian Device Exemption (HDE)Conformity AssessmentAuthorized RepresentativeIVDR (Regulation 2017/746)Marketing Authorization Holder (MAH)Establishment RegistrationDevice ListingPremarket NotificationSpecial 510(k)Abbreviated 510(k)EC REP (European Commission Representative)DMAL Holder (Designated Marketing Authorization Holder)Total Product Life Cycle (TPLC)Compassionate Use / Expanded AccessEmergency Use Authorization (EUA)ARTG (Australian Register of Therapeutic Goods)NHI (Japan National Health Insurance)
QUALITY SYSTEMS
STANDARDS
SAFETY SURVEILLANCE
Medical Device RecallMAUDE DatabaseAdverse EventVigilancePost-Market Surveillance (PMS)Field Safety Corrective Action (FSCA)MedWatchPeriodic Safety Update Report (PSUR)Serious Adverse EventDevice DeficiencyAEMS (Adverse Event Monitoring System)FAERS (FDA Adverse Event Reporting System)FDA Warning LetterMarket Surveillance
CLASSIFICATION
Class I Medical DeviceClass II Medical DeviceClass III Medical DevicePredicate DeviceSubstantial EquivalenceSoftware as a Medical Device (SaMD)Combination ProductCustom-Made DeviceClass IIa (EU MDR)Class IIb (EU MDR)Classification RuleAI/ML-Based Medical DeviceFDA Product CodePredicate CreepDigital Health
CLINICAL
DOCUMENTATION
Unique Device Identification (UDI)Technical DocumentationGeneral Safety and Performance Requirements (GSPR)Design History File (DHF)Device History Record (DHR)Device Master Record (DMR)Medical Device LabelingInstructions for Use (IFU)Summary of Safety and Clinical Performance (SSCP)Single Registration Number (SRN)Declaration of Conformity (DoC)GUDID (Global UDI Database)Clinical Evaluation Report (CER)