Acronyms
Acronym | Meaning |
|---|---|
Actor ID | Actor Identifier, unique identifier of an actor in EUDAMED |
ACT | Actor and by extension the Actor Module |
AR | Authorised Representative |
Basic UDI-DI | Basic Unique Device Identification – Device Identifier |
CRF | Certificate and by extension the Notified Body and Certificates module |
CI | Clinical Investigation |
CI/PS | Clinical Investigation and Performance Study Module |
CEAR | Clinical Evaluation Assessment Report |
CECP | Clinical Evaluation Consultation Procedure |
CER | Clinical Evaluation Report |
CA | Competent Authority |
CCA | Coordinating Competent Authority |
DD | Device Deficiency (in the context of CI/PS) |
DEV | UDI/Devices Module |
DA | Designating Authority |
DTX | Data Exchange |
EC | European Commission |
EMDN | European Medical Device Nomenclature |
EUDAMED DI | Equivalent of Basic UDI-DI, EUDAMED Device Identifier for legacy devices |
EUDAMED ID | Equivalent of UDI-DI, EUDAMED Device Identifier for legacy devices without a UDI-DI |
FSCA | Field Safety Corrective Action |
FSN | Field Safety Notice |
IM | Importer |
IVDR | In vitro Diagnostic Medical Devices Regulation |
LAA | Local Actor Administrator |
LUA | Local User Administrator |
M2M | Machine to Machine Data Exchange |
MDCG | Medical Device Coordination Group |
MDR | Medical Devices Regulation |
MF | Manufacturer |
MIR | Manufacturer Incident Report |
MS | Member State |
MSU | Market Surveillance and by extension the Market Surveillance Module |
NANDO | New Approach Notify and Designated Organisations Information System |
NB | Notified Body |
Non-EU MF | A manufacturer not established within the EU market (incl. EEA, Türkiye and Northern Ireland) |
PMCF | Post Market Clinical Follow-up |
PMPF | Post Market Performance Follow-up |
PRRC | Person Responsible for Regulatory Compliance |
PS | Performance Study |
PSR | Periodic Summary Report (on similar serious incidents) |
PSUR | Periodic Safety Update Report |
SP | Sponsor for CI/PS |
SPP | System and Procedure Pack |
SPPP | System and Procedure Pack Producer |
SAE | Serious Adverse Event |
SIN | Single Identification Number for CI/PS |
SRN | Single Registration Number (unique identifier of an Economic Operator Actor in EUDAMED) |
SS(C)P | Summary of Safety and (Clinical) Performance |
UDI | Unique Device Identification |
UDI-DI | Unique Device Identification – Device Identifier |
UoU DI | Unit of Use DI |
VGL | Vigilance and by extension Post-Market Surveillance and Vigilance Module |