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16.07.2025
|
Urgent Field Safety Notice for Philips Intera, Achieva, Ingenia CX by PHILIPS HEALTHCARE FRANCE
Product group Electromedical fields -
equipment for MR tomography
Reference 00718/24
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|
15.07.2025
|
Urgent Field Safety Notice for Atellica CH Diazo Total Bilirubin (D_TBil) by Siemens Healthcare Diagnostics Inc. Tarrytown
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 29269/25
|
|
15.07.2025
|
Urgent Field Safety Notice for SureTek Burr Hole Cover Kit by Boston Scientific Neuromodulation Corporation
Product group Active implantable medical devices -
biostimulators
Reference 30204/25
|
|
15.07.2025
|
Urgent Field Safety Notice for Automated Impella Controller by ABIOMED Inc.
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 27299/25
|
|
15.07.2025
|
Urgent Field Safety Notice for Epoc BGEM Test Cards by Epocal, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 30695/25
|
|
15.07.2025
|
Guidance for Applicants Scientific Advice
Guidance for Applicants Scientific Advice
|
|
14.07.2025
|
Radiation applications in combined clinical trials (clinical trials submitted to both CTIS and DMIDS)
For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.
|
|
14.07.2025
|
Urgent Field Safety Notice for Dexcom G7 Continuous Glucose Monitoring System by Dexcom, Inc
Product group Medical electronics / Electromedical devices -
electric blood glucose meters
Reference 20005/25
|
|
14.07.2025
|
Urgent Field Safety Notice for Cardiosave Intraaortic Balloon Pump by Datascope Corp., Interventional Products Division
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 34418/22
|
|
11.07.2025
|
Europe and EUDAMED
Further developing the safety and supply of medical devices, strengthening coordination and governance at EU level - The European medical device authorities have published a joint statement on the MDR and IVDR.
|
|
11.07.2025
|
Urgent Field Safety Notice for Vercise Genus by Boston Scientific Neuromodulation Corporation
Product group Active implantable medical devices -
biostimulators
Reference 26467/24
|
|
11.07.2025
|
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
Product group Medical data processing (software) -
others
Reference 14740/25
|
|
11.07.2025
|
Urgent Field Safety Notice for Rad-G Pulse Oximeter by Masimo Corporation
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 09986/24
|
|
11.07.2025
|
CAMD and HMA: European medical device competent authorities statement on reform of the EU regulatory framework for medical devices (July 2025)
|
|
10.07.2025
|
Urgent Field Safety Notice for CROSS Hemi Shoulder by Camp Scandinavia AB
Product group Orthopaedic / Rehabilitation technology -
orthoses
Reference 29381/25
|
|
10.07.2025
|
Urgent Field Safety Notice for MUTARS Proximales Femur (Revision) by implantcast GmbH
Product group Non-active implants -
bone surgery
Reference 21978/25
|
|
10.07.2025
|
Urgent Field Safety Notice for Ambu SPUR II by AMBU A/S
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 28516/25
|
|
10.07.2025
|
Medical Research Act
As of 1 July 2025, a centralised advice application portal from BfArM and the Paul-Ehrlich-Institut is available online on the PharmNet.Bund website.
|
|
09.07.2025
|
Presenation Iris Webinar July 2025
Presenation Iris Webinar July 2025
|
|
09.07.2025
|
Urgent Field Safety Notice for Hugo Ras Sterile Interface Module by Covidien llc
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 11690/25
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