22.01.2025
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Urgent Field Safety Notice for Pulsar-35 by BIOTRONIK AG
Product group Non-active implants -
special implants
Reference 01562/25
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22.01.2025
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Urgent Field Safety Notice for Allura Xper and Azurion systems by Philips Medical Systems Nederland B.V.
Product group Radiological technology -
radiological equipment for vascular diagnostics
Reference 16770/23
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22.01.2025
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Urgent Field Safety Notice for Video Processor, Video Colonoscopes, Video Upper GI Scopes by HOYA Corp., Pentax Tokyo Office
Product group Optics / Precision engineering -
endoscopes
Reference 01467/25
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22.01.2025
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Information Iris Webinar - February 2025
Information Iris Webinar - February 2025
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22.01.2025
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Iris user group meeting – save the date and register
The dates and information for the next Iris user group meeting are available.
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21.01.2025
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Urgent Field Safety Notice for NovaSeq 6000Dx by Illumina, Inc.
Product group In-vitro diagnostics -
instruments, apparatuses and systems
Reference 01263/25
|
21.01.2025
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Notification of interruptions or discontinuations of the supply of a medical device
Notification of interruptions or discontinuation of the supply of a medical device
|
20.01.2025
|
Current processing statistics of the BfArM
State: December 2024
|
20.01.2025
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Urgent Field Safety Notice for iGFBP-1 Rapid Test Cassette (Vaginal Secretion) by Hangzhou AllTest Biotech Co.,Ltd
Product group In-vitro diagnostics -
immunological products
Reference 01456/25
|
17.01.2025
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Urgent Field Safety Notice for Pocket adaptor kit for deep brain stimulation by Medtronic Inc
Product group Active implantable medical devices -
biostimulators
Reference 15614/24
|
17.01.2025
|
Urgent Field Safety Notice for Tack Endovascular System by Intact Vascular, Inc
Product group Non-active implants -
special implants
Reference 01244/25
|
17.01.2025
|
Urgent Field Safety Notice for Single Use Guide Sheath Kit by Olympus Medical Systems Corp.
Product group Optics / Precision engineering -
endoscopes
Reference 01415/25
|
16.01.2025
|
European database for medical devices: EUDAMED
MDR and IVDR conceptualize EUDAMED as the central platform for the European exchange of information and data on medical devices.
|
16.01.2025
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Urgent Field Safety Notice for 4008H, B, S. Art. Prometheus by Fresenius Medical Care AG & Co. KGaA
Product group Injections / Infusions / Transfusions / Dialysis -
dialysis technology
Reference 45042/24
|
16.01.2025
|
Urgent Field Safety Notice for MOSAIQ Oncology Information System by Elekta Solutions AB
Product group Radiotherapy / Radiation protection -
radiotherapy treatment planning systems
Reference 01043/25
|
16.01.2025
|
Responsibilities
DACO is currently under development, and its future tasks will be shaped based on the Health Data Use Act (Gesundheitsdatennutzungsgesetz, GDNG).
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16.01.2025
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Application Process
DACO has a broad range of responsibilities related to data access applications
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16.01.2025
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Metadata Catalog
The metadata catalog will serve as a central resource describing available datasets in the German healthcare sector and identifying the respective dataholders.
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16.01.2025
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EU Integration
DACO is actively working on the development of a Cross-Border Gateway, a key component of the HealthData@EU network within the EHDS.
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16.01.2025
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Secure Processing Environments (SPEs)
Secure Processing Environments (SPEs) are specialized technical and organizational infrastructures designed to enable the safe use of sensitive health data.
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