Regulatory & MR-MD-Trial Abbreviations (EU,CH)

🇪🇺 EU-specific abbreviations (with links)

Abbreviation	Meaning / Link
MDR	Medical Device Regulation (EU 2017/745)
IVDR	In Vitro Diagnostic Regulation
GSPR	General Safety and Performance Requirements
EUDAMED	European Database on Medical Devices
PRRC	Person Responsible for Regulatory Compliance
NB	Notified Body
CA	Competent authority (e.g. ethics committee)
EO	Economic Operator
EC Rep	European Authorised Representative
UDI	Unique Device Identifier
UDI-DI	UDI Device Identifier
UDI-PI	UDI Production Identifier
SSCP	Summary of Safety and Clinical Performance
PSUR	Periodic Safety Update Report
PMCF Plan	Post-Market Clinical Follow-up Plan
PMCF Report	Post-Market Clinical Follow-up Report
PMS Plan	Post-Market Surveillance Plan
PMS Report	Post-Market Surveillance Report
DoC	Declaration of Conformity
NB Op	Notified Body Opinion
CS	Common Specifications
MDGC	Medical Device Coordination Group

🇨🇭 Swiss-specific abbreviations (with links)

Abbreviation	Meaning / Link
BASEC	Swiss Ethics BASEC Portal
ClinO-MD	Swiss Ordinance on Clinical Trials with Medical Devices
HRA	Swiss Human Research Act
MedDO	Swiss Medical Devices Ordinance
TPA	Swiss Therapeutic Products Act
Swissmedic	Swiss Agency for Therapeutic Products
FOPH	Federal Office of Public Health
EK	Ethics Committee Switzerland

🇨🇭🇪🇺 Common / International + MRI/MRS + ISO/IEC abbreviations (with links)

Abbreviation	Meaning / Link
ISO 14155	Clinical investigations of medical devices standard
ISO 13485	Medical device quality management systems
ISO 14971	Risk management for medical devices
IEC 60601-2-33	MRI equipment safety standard
AE	Adverse Event (ICH GCP)
SAE	Serious Adverse Event
SUSAR	Suspected Unexpected Serious Adverse Reaction
IFU	Instructions for Use
ISF TMF	Investigator Site File
PMS	Post-Market Surveillance
PMCF	Post-Market Clinical Follow-up
CER	Clinical Evaluation Report
CAPA	Corrective and Preventive Action
FMEA	Failure Modes and Effects Analysis
FTA	Fault Tree Analysis
CRF	Case Report Form
GCP	Good Clinical Practice (ICH)
QMS	Quality Management System
IEC	International Electrotechnical Commission
ISO	International Organization for Standardization
SAR	Specific Absorption Rate
pNS	Peripheral Nerve Stimulation
IB	Investigator’s Brochure
CI	Clinical investigator
CIP	Clinical Investigation Plan
UHF-MRI	Ultra High Field MRI (7T+)
MRSI	Magnetic Resonance Spectroscopic Imaging
MRS	Magnetic Resonance Spectroscopy
ROI	Region of Interest
FID	Free Induction Decay
B₀	Main magnetic field strength
B_1⁺	RF magnetic field
pTx	Parallel Transmission
TR	Repetition Time
TE	Echo Time
TI	Inversion Time
WIP	Work In Progress sequence
IDEA	Siemens sequence development environment
SLOW-EPSI	Specialized MRSI sequence
BASEC-ID	Swiss EC project ID (BASEC)
FDA	US Food and Drug Administration