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17.04.2025
|
Urgent Field Safety Notice for Mecta-C Stand Alone screws by Medacta International SA
Product group Non-active implants -
bone surgery
Reference 15287/25
|
|
17.04.2025
|
Iris user survey
The Iris user survey is now available!
|
|
16.04.2025
|
Urgent Field Safety Notice for Codman Certas Programmable Valve System by Integra LifeSciences Mansfield
Product group Non-active implants -
special implants
Reference 02820/13
|
|
16.04.2025
|
Presentation Iris Webinar April 2025
Presentation Iris Webinar April 2025
|
|
16.04.2025
|
Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc
Product group Medical electronics / Electromedical devices -
electric blood glucose meters
Reference 00725/25
|
|
16.04.2025
|
Iris user questionnaire April 2025
Iris user questionnaire April 2025
|
|
16.04.2025
|
Publication of the Joint Announcement by the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines (PEI) on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013
The Joint Announcement of BfArM and PEI replaces the second Announcement on the notification of variations for purely national licences in accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 which are within the BfArM's responsibility in accordance with Section 77 dated 15 June 2016 and considers the amendments to the Variation Regulation (Regulation (EC) No. 1234/2008) following the entry into force of Commission Delegated Regulation (EU) 2024/1701.
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|
16.04.2025
|
Medical Research Act
Publication of the Joint Announcement by BfArM and PEI on the Notification of Variations for Purely National Marketing Authorisation
|
|
16.04.2025
|
Request for supergrouping
Request for supergrouping
|
|
16.04.2025
|
Variations
Publication of the Joint Announcement by BfArM and PEI on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 dated 16 April 2025
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|
15.04.2025
|
Information Iris user group meeting - May 2025
Information Iris user group meeting - May 2025
|
|
15.04.2025
|
Urgent Field Safety Notice for AirLife Infant Heated Wire Circuits by Vyaire Medical Mettawa
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 14591/25
|
|
15.04.2025
|
Urgent Field Safety Notice for HMRS and KRH by Stryker Orthopaedics-Mahwah
Product group Non-active implants -
bone surgery
Reference 14552/25
|
|
15.04.2025
|
Urgent Field Safety Notice for CODMAN Disposable Perforator (Codman Einmalbohrer) by Integra LifeSciences Corp.
Product group Medical instruments for use in humans -
bone surgery
Reference 14566/25
|
|
14.04.2025
|
Urgent Field Safety Notice for Brilliance CT Big Bore; Philips CT Big Bore by Philips Medical Systems Nederland B.V.
Product group Radiological technology -
CT scanners
Reference 13305/25
|
|
14.04.2025
|
Urgent Field Safety Notice for MiniHip by Corin Medical Ltd.
Product group Non-active implants -
bone surgery
Reference 14413/25
|
|
14.04.2025
|
Urgent Field Safety Notice for Microstream Advance, VitaLine, FilterLine by Philips Medizin Systeme Böblingen GmbH
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 14402/25
|
|
14.04.2025
|
Urgent Field Safety Notice for SmartLink 3 by SOFTWARE TEAM SRL
Product group Medical data processing (software) -
Facette_Produktgruppe_09md-07
Reference 14319/25
|
|
14.04.2025
|
Urgent Field Safety Notice for DxC 500i Clinical Analyzer by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 14043/25
|
|
11.04.2025
|
Urgent Field Safety Notice for Carestation 600 and 750 Series by Datex-Ohmeda, Inc.
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 12079/25
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