Manufacturer Incident Report (MIR)for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)
Reporting Template Version 7.0 EU Medical Devices Vigilance SystemGuidelines and Annexes
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Manufacturer Incident Report (MIR)for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)
Reporting Template Version 7.0 EU Medical Devices Vigilance SystemGuidelines and Annexes
The European Commission published its recommendation for a common framework (...)
Revision 8 of MEDDEV 2.12-1, the new European Medical Device Vigilance (...)
As soon as the European Commission published the proposed new European (...)
The French decree regarding the list of medical devices for which (...)
BREXIT: What will happen after March 29, 2019 in case of no deal ?
European Commission published a series of factsheets and infographics as (...)
From : EUROPEAN COMMISSION RELEASE - Brussels, 22 January 2018 - REV.1
NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF MEDICAL DEVICES
MediMark Europe has made a selection of documents which may help you to (...)
Decision of the Council of State: The RCD decree concerning the need to send to ANSM, the French NCA, a summary of the characteristics for Class 2b implantable and 3 devices, has no legal basis and can only be canceled.
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