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01.07.2025
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Example Briefing Document DiPA Advice
Example Briefing Document DiPA Advice
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01.07.2025
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Example Briefing Document DiGA Advice
Example Briefing Document DiGA Advice
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01.07.2025
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Pre-advice & DiGA-/DiPA-consultation by the Innovation Office at the Federal Institute for Drugs and Medical Devices (BfArM)
Guidance to applicants
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01.07.2025
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Urgent Field Safety Notice for Becker and Exacta External Drainage and Monitoring System by Medtronic Inc
Product group Injections / Infusions / Transfusions / Dialysis -
drainages and suction systems
Reference 38516/24
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01.07.2025
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Urgent Field Safety Notice for BD FACS 7-Color Setup Beads by Becton Dickinson Biosciences
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 25201/25
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01.07.2025
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Urgent Field Safety Notice for INNOVANCE VWF Ac by Siemens Healthcare Diagnostics Products GmbH
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 25502/25
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01.07.2025
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Urgent Field Safety Notice for ACL TOP 970 CL by Instrumentation Laboratory Co.
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 27696/25
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01.07.2025
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Urgent Field Safety Notice for ri-thermo tymPRO+ with Smart Cradle by Rudolf Riester GmbH & Co. KG
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 26799/25
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01.07.2025
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Urgent Field Safety Notice for Revolution Apex, Revolution CT by GE Medical Systems LLC
Product group Radiological technology -
CT scanners
Reference 10089/25
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01.07.2025
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Urgent Field Safety Notice for Recharger Kit by Medtronic Inc
Product group Active implantable medical devices -
biostimulators
Reference 32276/24
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01.07.2025
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DRKS - List of all studies registered in 2025
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02.07.2025
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Urgent Field Safety Notice for SWISS optio regflow by Gebr. Gloor AG
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 27126/25
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02.07.2025
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Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 25450/25
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02.07.2025
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Urgent Field Safety Notice for Injection needle by Spiggle & Theis Medizintechnik GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
syringes and cannulas
Reference 27934/25
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02.07.2025
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Urgent Field Safety Notice for BiPAP A40 Pro, BiPAP A40 EFL, BiPAP A30 EFL by Respironics, Inc. Pittsburgh
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 20133/24
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03.07.2025
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Urgent Field Safety Notice for POLYCENTRIC 4 BAR MANUAL LOCKING KNEE by Regal Prosthesis Ltd
Product group Non-active implants -
bone surgery
Reference 27664/25
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04.07.2025
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Submission of Variations
Aerosol dispensers containing fluorinated greenhouse gases, including medicinal metered dose inhalers, may only be placed on the market, supplied or made available to third parties in the EU from 1 January 2025 if they are labelled in accordance with Article 12(3) of Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-Gas Regulation).
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08.07.2025
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Urgent Field Safety Notice for 3mensio Workstation by Pie Medical Imaging B.V.
Product group Medical data processing (software) -
software for computer-based treatment
Reference 28334/25
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08.07.2025
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Urgent Field Safety Notice for Unity Femoral Sizer by Corin Medical Ltd.
Product group Medical instruments for use in humans -
bone surgery
Reference 29300/25
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08.07.2025
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Urgent Field Safety Notice for Achieva 3.0T/XR, Evolution upgrade 1.5T/3.0T, Ingenia 1.5T/1.5T S/3.0T/3.0T CX/Ambition S/Ambition X/Elition S/Elition X/Intera 3.0T Quasar Dual, MR 5300, MR 7700, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0 by Philips Medical Systems Nederland B.V.
Product group Electromedical fields -
equipment for MR tomography
Reference 28689/25
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