Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
PRAC Strategy on Measuring Pharmacovigilance Activities
In 2017, PRAC established a strategy for measuring the impact of pharmacovigilance activities, and EMA has published a second revision in April 2022. The second revision of the PRAC Impact Strategy integrates the achievements over a five-year period since its launch in [...]
The EUDAMED UDI/devices module updated technical documentation is available
The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device enumerations v2.7 MDR and IVDR introduce an EU device [...]
EUDAMED UDI/devices Updated Technical Documentation Module
The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device enumerations v2.7 MDR and IVDR introduce an EU device [...]
EMA’s advice on managing the impact of the war in Ukraine
EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]
EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A
The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors [...]
BVMed and SNITEM: Overcoming the MDR implementation bottleneck
The BVMed - German Medical Technology Association and SNITEM - the French National union of the medical technology industry are launching a Franco-German initiative for Medical Device Regulation. In a joint statement, they call for three important points and [...]
