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Tag Archives: CE Mark

BREXIT and Medical Device Registration
07 Dec

Industry Update: Interesting news on – BREXIT and Medical Device Registration

As of January 1, 2021, the UK’s departure from the EU will begin. As of that date, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the medical devices market for the UK that are currently undertaken through the EU system. This calls for several changes to how medical devices

07 Jul

Overview of the biggest changes brought about by the MDR

Changes for the CE mark requirements. Supplied by mdi-Europa Below is a short summary of the most important changes that are coming our way with the new MDR. Some of these have been discussed before in our newsletters and / or mailings, however, the below article gives another complete overview: Liability: Insurance coverage for manufacturers

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