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Date Title:
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 Carotid Wallstent Monorail by Boston Scientific Corporation Marlborough

Product group Non-active implants - special implants
Reference 29555/25

09.07.2025 Urgent Field Safety Notice for UniCel DxI 800 Access Immunoassay-Analysegerät und weitee by Beckman Coulter

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 29764/25

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

09.07.2025 Urgent Field Safety Notice for Philips Intera, Achieva, Ingenia CX by PHILIPS HEALTHCARE FRANCE

Product group Electromedical fields - equipment for MR tomography
Reference 32635/23

08.07.2025 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

08.07.2025 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

08.07.2025 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

08.07.2025 Urgent Field Safety Notice for lifecath CT PICC easy by VYGON GmbH & Co. KG

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 29361/25

08.07.2025 Urgent Field Safety Notice for Heater Unit HU35 by Maquet Cardiopulmonary AG

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10605/22

08.07.2025 Urgent Field Safety Notice for Micro Joystick R-net, Multi Joystick R-net, All-round Joystick (Light) R-net, Heavy Duty Joystick R-net by mo-Vis bv

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 27077/25

08.07.2025 Urgent Field Safety Notice for Q-Link 13, Adapter kit LikoScale, and LIKO UNO 102 EE Mobile lift by Liko AB

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 26673/25

08.07.2025 Urgent Field Safety Notice for Nellcor Bedside SpO2 Monitor by Covidien llc

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 27511/25

08.07.2025 Urgent Field Safety Notice for Infinia and VG Series Nuclear Medicine systems by GE Medical Systems Israel, Functional Imaging

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 28681/25

04.07.2025 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).
03.07.2025 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

02.07.2025 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

02.07.2025 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

02.07.2025 Urgent Field Safety Notice for Injection needle by Spiggle & Theis Medizintechnik GmbH

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 27934/25