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New Medical Device Directive

EU

Finally some progress! The final versions of the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, resp.) have finally been approved by the European Parliament on April 5th 2017. Formal publication of the MDR and IVDR in the Official Journal of the European Union is anticipated for early May 2017. Twenty days from that publication, likely in early June 2017, the Regulations will enter into force. Accordingly, the MDR will probably be applicable by 2020 and the IVDR by 2022.

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