BfArM - Federal Institute for Drugs and Medical Devices

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23.12.2025 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

23.12.2025 Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 57335/25

23.12.2025 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

23.12.2025 Urgent Field Safety Notice for monsoon 4 by Thora Tech GmbH

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 61692/25

19.12.2025 Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.

Product group Radiological technology - stationary radiological equipment
Reference 55491/25

19.12.2025 Urgent Field Safety Notice for basixCOMPAK Inflation Device by Merit Medical Systems Inc.

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 56933/25

19.12.2025 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

19.12.2025 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

19.12.2025 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

19.12.2025 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

19.12.2025 Current processing statistics of the BfArM

State: November 2025
19.12.2025 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.

19.12.2025 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.

19.12.2025 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

18.12.2025 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.
18.12.2025 Urgent Field Safety Notice for NOxBOXi by NOxBOX Ltd

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 55827/25

17.12.2025 Winter Clock Stop for Clinical Trial Applications

Winter Clock Stop for Clinical Trial Applications from 22 Dec 2025 to 8 Jan 2026
17.12.2025 Urgent Field Safety Notice for Vanta/Sequentia LT Clinician Programmer Application by Medtronic Inc

Product group Active implantable medical devices - programming and control equipment
Reference 57621/25

16.12.2025 Urgent Field Safety Notice for BD Alaris System Infusion Pump by BD Switzerland Sarl

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 48593/25

16.12.2025 Urgent Field Safety Notice for SECUTRAY Angio-Set by SENGEWALD Klinikprodukte GmbH

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 54272/25