The European Commission published its recommendation for a common framework (...)
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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 (...)
The publication of the Commission’s revision proposal to the Council and (...)
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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