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
About NBs
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
Free one-hour webinar offered by BSI experts on MHRA last early September released guidance and UK "brexiting issues" regarding all medical devices to be ready for no later than next January 01, 2021 !
2020-09-01 and 04 - MHRA UK - post-transtion period -Medical, Clinical and medicinal - NEW RULES FROM 01 JANUARY 2021
September-03-2020 Updated list of NBs notified under EU Regulations on MD and IVD and their detailed framework.
Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use device.Released 20 August 2020
TÜV SÜD designation for IVDR
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