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29.12.2025
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Urgent Field Safety Notice for Access Port Kit by Intuitive Surgical, Inc.
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 60780/25
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29.12.2025
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Urgent Field Safety Notice for Schwenkbare Aufstehhilfe by Burmeier GmbH & Co. KG
Product group General equipment for medical treatment -
furnishings
Reference 60439/25
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23.12.2025
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Urgent Field Safety Notice for Evolution Upgrade 1.5T, 3.0T; Ingenia 1.5T, 3.0T, 3.0T CX; Ingenia 3.0T CX; Ingenia Ambition S. X; Ingenia Elition S. X; MR 7700; Upgrade to MR 7700; SmartPath to dStream for 3.0T, XR and 3.0T by Philips Medical Systems Nederland B.V.
Product group Electromedical fields -
equipment for MR tomography
Reference 58411/25
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23.12.2025
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Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
Product group Radiotherapy / Radiation protection -
radiotherapy treatment planning systems
Reference 57335/25
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23.12.2025
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Urgent Field Safety Notice for BD neXus V700 Infusion, S700 Syringe Pumps by MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 56891/25
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23.12.2025
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Urgent Field Safety Notice for monsoon 4 by Thora Tech GmbH
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 61692/25
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22.12.2025
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22 December 2025: Clinical investigation/performance study (KP/LS) in accordance with MDR, IVDR and MPDG
A new guidance for sponsors has been published: Clinical investigation/performance study (KP/LS) in accordance with MDR, IVDR and MPDG
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19.12.2025
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Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.
Product group Radiological technology -
stationary radiological equipment
Reference 55491/25
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19.12.2025
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Urgent Field Safety Notice for basixCOMPAK Inflation Device by Merit Medical Systems Inc.
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 56933/25
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19.12.2025
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Urgent Field Safety Notice for cobas c 703 analytical unit by Roche Diagnostics GmbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 57337/25
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19.12.2025
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Urgent Field Safety Notice for Automated Tube Sorter TS-10 by Sysmex Japan Corporation
Product group In-vitro diagnostics -
instruments, apparatuses and systems
Reference 58724/25
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19.12.2025
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Urgent Field Safety Notice for Syringe 10ml L/L 3parts Red plunger, (TAVI Set, AnngioSet) by Mölnlycke Health Care AB (Molndal)
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 59615/25
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19.12.2025
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Urgent Field Safety Notice for Microsensor /CereLink ICP sensor Basic kit by Integra LifeSciences Corp.
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 60424/25
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19.12.2025
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Current processing statistics of the BfArM
State: November 2025
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19.12.2025
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Marketable medicinal products in the responsibility of the BfArM
On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are updated on a monthly basis.
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19.12.2025
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Processing statistics
Here the BfArM publishes the current processing statistics of authorisations and registrations as well as of renewals. The figures are updated on a monthly basis.
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19.12.2025
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Urgent Field Safety Notice for N-Histofine DAB-2V by Nichirei Biosciences Inc.
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 58098/25
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18.12.2025
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Notification of Medical Devices and In vitro Diagnostics
Medical devices and in vitro diagnostic devices as well as information on the PRRC have to be notified via DMIDS until 28 May 2026.
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18.12.2025
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Urgent Field Safety Notice for NOxBOXi by NOxBOX Ltd
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 55827/25
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17.12.2025
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Winter Clock Stop for Clinical Trial Applications
Winter Clock Stop for Clinical Trial Applications from 22 Dec 2025 to 8 Jan 2026
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