Below is a helpful list of acronyms and abbreviations that are commonly used in the EU MDR 2017/745 space and clinical trials.
| TERM | DEFINITION |
| ADME | Absorption, Distribution, Metabolism, and Excretion |
| AE | Adverse Event |
| AESI | Adverse Event of Special Interest |
| AI | Application Identifier |
| AIDC | Automatic Identification and Data Capture |
| AIMD | Active Implantable Medical Device |
| AIMDD | Active Implantable Medical Device Directive |
| API | Application Programming Interface |
| AUC | Area Under (the) Curve |
| BfArM | Bundesinstitut für Arzneimittel und Medizinprodukte |
| BLA | Biologics License Application |
| BSI | British Standards Institute |
| CA | Competent Authority |
| CAMD | Competent Authorities for Medical Devices |
| CAPA | Corrective and Preventive Action |
| CDx | Companion Diagnostic(s) |
| CE | Conformité Européenne |
| CEC | Clinical Ethics Committee |
| CEP | Clinical Evaluation Plan |
| CER | Clinical Evaluation Report |
| CFR | (USA) Code of Federal Regulations |
| CFU/mL | Colony-forming units per mL |
| CHMP | Committee for Medicinal Products for Human Use |
| CIED | Cardiac Implantable Electronic Device |
| CIP | Clinical Investigation Plan |
| CIR | Clinical Investigation Report |
| CIV-ID | Clinical Investigation Identification |
| CLIA | Clinical Laboratory Improvement Amendments |
| ClinOps | Clinical Operations |
| CMR | Carcinogenic, Mutagenic or toxic to Reproduction |
| CND | Classificazione Nazionale Dispositivi Medici |
| CoA | Certificate of Analysis |
| CRF | Case Report Form |
| CRO | Contract Research Organization |
| CS | Common Specifications/Standard(s) |
| CTA | Clinical Trial Application |
| CTD | Common Technical Document |
| CTN | Clinical Trials Network |
| DAEN | Database of Adverse Event Notifications |
| DCS | Document Control System |
| DHF | Design History File (see FDA 21 CFR Part 820.30) |
| DHR | Device History Record |
| DMPK | Drug Metabolism and Pharmacokinetics |
| DMR | Device Master Record (see FDA 21 CFR Part 820.40) |
| DOI | Declaration of Interest |
| DSMB | Data Safety Monitoring Board |
| DSUR | Development Safety Update Report |
| DSVG | Device-Specific Vigilance Guidance |
| EAC | External Assessment Centre |
| ECA | European Chemicals Agency |
| EFSA | European Food Safety Authority |
| EMA | European Medicines Agency |
| EMDN | European Medical Device Nomenclature |
| eQMS | Electronic Quality Management System |
| ER | Essential Requirement(s) |
| EU | European Union |
| EUA | Emergency Use Authorization |
| EUDAMED | European database on medical devices |
| FDA | Food and Drug Administration |
| GHTF | Global Harmonization Task Force |
| GMDNS | Global Medical Device Nomenclature System |
| GSPR | General Safety and Performance Requirement(s) |
| HRI | Human Readable Interpretation |
| ICF | Informed Consent Form |
| IFU | Instructions for Use |
| IMDRF | International Medical Device Regulators Forum |
| IMPD | Investigational Medicinal Product Dossier |
| IND | Investigational New Drug |
| IRB | Institutional Review Board |
| IVDMD | In Vitro Diagnostic Medical Device |
| IVDMDD | In Vitro Diagnostic Medical Device Directive |
| IVDR | In Vitro Diagnostic Device Regulation |
| MAA | Marketing Authorization Application |
| MAUDE | Manufacturer and User Facility Device Experience Database |
| MDCG | Medical Device Coordination Group |
| MDD | Medical Device Directive |
| MDR | Medical Device Regulation |
| MEDDEV | Medical Devices Documents |
| MedDRA | Medical Dictionary for Regulatory Activities |
| MHRA | Medicines and Healthcare Products Regulatory Agency |
| NANDO | New Approach Notified and Designated Organisations |
| NB | Notified Body |
| NDA | New Drug Application / Non-Disclosure Agreement |
| NICE | National Institute for Health and Clinical Excellence |
| NIDA | National Institute on Drug Abuse |
| NPI | New Product Introduction |
| OCEBM | Oxford Centre for Evidence-Based Medicine |
| PD | Pharmacodynamics |
| PEP | Performance Evaluation Plan |
| PER | Performance Evaluation Report |
| PFU/mL | The number of infective particles within the sample; based on the assumption that each plaque formed is representative of one infective virus particle |
| PICO | Patient characteristics, type of Intervention, Comparator group(s)/Control(s), and Outcome(s)/endpoint(s) |
| PK | Pharmacokinetics |
| PMC | PubMed Central |
| PMCF | Post-Market Clinical Follow-up |
| PMCFP | Post-Market Clinical Follow-up Plan |
| PMCFR | Post-Market Clinical Follow-up Report |
| PMPF | Post-Market Performance Follow-up |
| PMPFP | Post-Market Performance Follow-up Plan |
| PMPFR | Post-Market Performance Follow-up Report |
| PMSP | Post-Market Surveillance Plan |
| PMSS | Post-Market Surveillance System |
| PRRC | Person Responsible for Regulatory Compliance |
| PSUR | Periodic Safety Update Report |
| PT | Preferred Term |
| PTF | Product Technical File |
| QMS | Quality Management System |
| R&D | Research and Development |
| RA | Regulatory Affairs |
| RCT | Randomized Controlled Trial |
| REMS | Risk Evaluation and Mitigation Strategy |
| RFID | Radio-Frequency Identification |
| RMS | Risk Management System |
| SAE | Serious Adverse Event |
| SIN | Single Identification Number |
| SOC | System Organ Class |
| SOTA | State-of-the-Art |
| SRN | Single Registration Number |
| SSCP | Summary of Safety and Clinical Performance |
| SSP | Summary of Safety and Performance |
| STARD | Standards for Reporting Diagnostic Accuracy Studies Initiative |
| STeD | Summary Technical Documentation |
| TCID50 | Median Tissue Culture Infectious Dose |
| TEAE | Treatment-Emergent Adverse Event |
| TF | Technical File |
| TFEU | Treaty on the Functioning of the European Union |
| TGA | Therapeutic Goods Administration |
| TPLC | Total Product Life Cycle |
| TÜV SÜD | Technischer Überwachungsverein Süd |
| UDI | Unique Device Identification |
| UDI-DI | Unique Device Identification-Device Identifier |
| UDI-PI | Unique Device Identification-Production Identifier |
| URL | Uniform Resource Locator |
| US(A) | United States (of America) |
| WET | Well-Established Technology |
