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18.07.2025
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Urgent Field Safety Notice for SIGNA Artist, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR by GE MEDICAL SYSTEMS LLC / GE HANGWEI MEDICAL SYSTEMS CO. LTD / GE HEALTHCARE JAPAN CORPORATION
Product group Electromedical fields -
equipment for MR tomography
Reference 32170/25
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18.07.2025
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Urgent Field Safety Notice for SIGNA Artist, SIGNA Artist Evo, SIGNA Voyager by GE HEALTHCARE (TIANJIN) COMPANY LIMITED
Product group Electromedical fields -
equipment for MR tomography
Reference 32171/25
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18.07.2025
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Urgent Field Safety Notice for VentStar Helix heated (N) Plus, VentStar Helix dual b (N) Plus, VentStar Aquapor dual (N) Plus by Drägerwerk AG & Co. KGaA
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 32266/25
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17.07.2025
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Urgent Field Safety Notice for Multiva 1.5T by Philips Healthcare (Suzhou) Co.,Ltd
Product group Electromedical fields -
equipment for MR tomography
Reference 32631/23
|
|
17.07.2025
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Urgent Field Safety Notice for BD Trucount Control Bead Kit, 30 test, CE-IVD by Becton, Dickinson and Company Milpitas
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 29509/25
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17.07.2025
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Urgent Field Safety Notice for Philips Allura system by Philips Medical Systems Nederland B.V.
Product group Radiological technology -
radiological equipment for vascular diagnostics
Reference 29569/25
|
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16.07.2025
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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
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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
|
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15.07.2025
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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
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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
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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.
|
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14.07.2025
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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
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|
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.
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11.07.2025
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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)
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