TÜV Rheinland Issues MDR Certificate to Ezisurg ...

'Revision of MedDO and IvDO: New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) /607 on medical devices and in vitro diagnostic medical devices The Federal Council has decided to amend the Medical Devices Ordinance (MedDO) to improve the safety of products without an intended medical purpose). Switzerland has adapted its MedDO for these products in line with the EU requirements (Implementing Regulation /) taking into account the new transitional periods. The required amendments to the MedDO have been approved and will enter into force on 1 November . Amendments of the EU-MDR /745 regarding transitional periods for certificates, and of the EU-MDR and EU-IVDR /746 regarding the elimination of deadlines for putting into service and placing on the market, were published in the EU on 20 March . Swissmedic published a communication on enforcement in March . The provisions have now been transposed into the ordinances in Switzerland and approved by the Federal Council.

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