Acronyms & Abbreviations

Below is a helpful list of acronyms and abbreviations that are commonly used in the EU MDR 2017/745 space and clinical trials.

ADMEAbsorption, Distribution, Metabolism, and Excretion
AEAdverse Event
AESIAdverse Event of Special Interest
AIApplication Identifier
AIDCAutomatic Identification and Data Capture
AIMDActive Implantable Medical Device
AIMDDActive Implantable Medical Device Directive
APIApplication Programming Interface
AUCArea Under (the) Curve
BfArMBundesinstitut für Arzneimittel und Medizinprodukte
BLABiologics License Application
BSIBritish Standards Institute
CACompetent Authority
CAMDCompetent Authorities for Medical Devices
CAPACorrective and Preventive Action
CDxCompanion Diagnostic(s)
CECClinical Ethics Committee
CEPClinical Evaluation Plan
CERClinical Evaluation Report
CFR(USA) Code of Federal Regulations
CFU/mLColony-forming units per mL
CHMPCommittee for Medicinal Products for Human Use
CIPClinical Investigation Plan
CIRClinical Investigation Report
CLIAClinical Laboratory Improvement Amendments
ClinOpsClinical Operations
CMRCarcinoenic, Mutagenic or toxic to Reproduction
CNDClassificazione Nazionale Dispositivi Medici
CoACertificate of Analysis
CRFCase Report Form
CROContract Research Organization
CSCommon Specifications/Standard(s)
CTAClinical Trial Application
CTDCommon Technical Document
CTNClinical Trials Network
DAENDatabase of Adverse Event Notifications
DCSDocument Control System
DHFDesign History File (see FDA 21 CFR Part 820.30)
DHRDevice History Record
DMPKDrug Metabolism and Pharmacokinetics
DMRDevice Master Record (see FDA 21 CFR Part 820.40)
DOIDeclaration of Interest
DSMBData Safety Monitoring Board
DSURDevelopment Safety Update Report
EACExternal Assessment Centre
ECAEuropean Chemicals Agency
EFSAEuropean Food Safety Authority
EMAEuropean Medicines Agency
EMDNEuropean Medical Device Nomenclature
eQMSElectronic Quality Management System
EREssential Requirements
EUEuropean Union
EUAEmergency Use Authorization
EUDAMEDEuropean database on medical devices
FDAFood and Drug Administration
GHTFGlobal Harmonization Task Force
GMDNSGlobal Medical Device Nomenclature System
GSPRGeneral Safety and Performance Requirements
HRIHuman Readable Interpretation
ICFInformed Consent Form
IFUInstructions for Use
IMDRFInternational Medical Device Regulators Forum
IMPDInvestigational Medicinal Product Dossier
INDInvestigational New Drug
IRBInstitutional Review Board
IVDMDIn Vitro Diagnostic Medical Device
IVDMDDIn Vitro Diagnostic Medical Device Directive
IVDRIn Vitro Diagnostic Device Regulation
MAAMarketing Authorization Application
MAUDEManufacturer and User Facility Device Experience Database
MDCGMedical Device Coordination Group
MDDMedical Device Directive
MDRMedical Device Regulation
MEDDEVMedical Devices Documents
MedDRAMedical Dictionary for Regulatory Activities
MHRAMedicines and Healthcare Products Regulatory Agency
NANDONew Approach Notified and Designated Organisations
NBNotified Body
NDANew Drug Application / Non-Disclosure Agreement
NICENational Institute for Health and Clinical Excellence
NIDANational Institute on Drug Abuse
NPINew Product Introduction
PEPPerformance Evaluation Plan
PERPerformance Evaluation Report
PFU/mLThe number of infective particles within the sample; based on the assumption that each plaque formed is representative of one infective virus particle
PICOPatient characteristics, type of Intervention, Comparator group(s)/Control(s), and Outcome(s)/endpoint(s)
PMCPubMed Central
PMCFPost-Market Clinical Follow-up
PMCFPPost-Market Clinical Follow-up Plan
PMCFRPost-Market Clinical Follow-up Report
PMPFPost-Market Performance Follow-up
PMPFPPost-Market Performance Follow-up Plan
PMPFRPost-Market Performance Follow-up Report
PMSPPost-Market Surveillance Plan
PMSSPost-Market Surveillance System
PRRCPerson Responsible for Regulatory Compliance
PSURPeriodic Safety Update Report
PTPreferred Term
PTFProduct Technical File
QMSQuality Management System
R&DResearch and Development
RARegulatory Affairs
RCTRandomized Controlled Trial
REMSRisk Evaluation and Mitigation Strategy
RFIDRadio-Frequency Identification
RMSRisk Management System
SAESerious Adverse Event
SOCSystem Organ Class
SRNSingle Registration Number
SSCPSummary of Safety and Clinical Performance
SSPSummary of Safety and Performance
STARDStandards for Reporting Diagnostic Accuracy Studies Initiative
STeDSummary Technical Documentation
TCID50Median Tissue Culture Infectious Dose
TEAETreatment-Emergent Adverse Event
TFTechnical File
TFEUTreaty on the Functioning of the European Union
TGATherapeutic Goods Administration
TPLCTotal Product Life Cycle
TÜV SÜDTechnischer Überwachungsverein Süd
UDIUnique Device Identification
UDI-DIUnique Device Identification-Device Identifier
UDI-PIUnique Device Identification-Production Identifier
URLUniform Resource Locator
USUnited States
WETWell-Established Technology

Expand your knowledge on the EU MDR 2017/745, and take off with a flying start.
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