2019-07-15 - More about Notified Bodies out or in the run for MD/IVDR...
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2019-07-15 - More about Notified Bodies out or in the run for MD/IVDR...
Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
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Meddev guidelines and templates for the management of FSCA and recalls in Europe Application : 2019
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
UDI : The two last MDCG Guidances for implementing the UDI into your (...)
Jan 15 2021 EU DG SANTE position about Brexit
AR SRN just granted to MediMark Europe
2020-NOV MDCG 2020-16 Guidance on Classification Rules for ivd MDs under 2017-746_en
2020-SEPT-16 _ 3EC International, Slovakia, becomes the 17th NB accredited for MDR under ref NB-2265
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