|
02.07.2025
|
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
|
|
01.07.2025
|
DRKS - List of all studies registered in 2025, as of 2025/09/30
|
|
01.07.2025
|
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
|
|
01.07.2025
|
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
|
|
01.07.2025
|
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
|
|
01.07.2025
|
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
|
|
01.07.2025
|
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
|
|
01.07.2025
|
Urgent Field Safety Notice for Revolution Apex, Revolution CT by GE Medical Systems LLC
Product group Radiological technology -
CT scanners
Reference 10089/25
|
|
01.07.2025
|
Urgent Field Safety Notice for Recharger Kit by Medtronic Inc
Product group Active implantable medical devices -
biostimulators
Reference 32276/24
|
|
01.07.2025
|
Pre-advice & DiGA-/DiPA-consultation by the Innovation Office at the Federal Institute for Drugs and Medical Devices (BfArM)
Guidance to applicants
|
|
01.07.2025
|
Example Briefing Document DiPA Advice
Example Briefing Document DiPA Advice
|
|
01.07.2025
|
Example Briefing Document DiGA Advice
Example Briefing Document DiGA Advice
|
|
30.06.2025
|
Urgent Field Safety Notice for CATCHVIEW by BALT Extrusion
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 27895/25
|
|
30.06.2025
|
Request for super-grouping
Request for super-grouping
|
|
27.06.2025
|
Procedure for notifiable radiation applications from 1 July 2025
In order to simplify the administrative procedure for radiation applications subject to notification in accordance with Section 32 of the Radiation Protection Act (StrlSchG) in the context of clinical investigations pursuant to the Medicinal Products Act (AMG) or Regulation (EU) 2017/745 on medical devices (MDR), a change of responsibility will take effect on 1 July 2025.
|
|
27.06.2025
|
Urgent Field Safety Notice for Sterile surgical procedure drape and Sterile Drape Packs by Medline International France SAS
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 27519/25
|
|
27.06.2025
|
Angusta (misoprostol for induction of labour): Reports of overdose and contraindicated use with labour already in progress
Active substance: misoprostol
Reminder of the authorisation-compliant application.
|
|
26.06.2025
|
Urgent Field Safety Notice for Estrone RIA, DSL-8700 by Immunotech a. s.
Product group In-vitro diagnostics -
immunological products
Reference 27353/25
|
|
26.06.2025
|
Urgent Field Safety Notice for corpuls3 by GS Elektromedizinische Geräte G. Stemple GmbH
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 25922/25
|
|
26.06.2025
|
Urgent Field Safety Notice for Untersuchungsliege by AGA Sanitätsartikel GmbH
Product group Physical therapy -
massage / mobility devices
Reference 22888/25
|
