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Focus on Regulation

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic Medical Devices Regulation (“IVDR”). The MDR and IVDR will apply from May 2020 and May 2022 respectively.

These documents include:

These documents include high-level information concerning the main changes introduced by the MDR and IVDR, guidance concerning the transitional provisions or the Regulations and “frequently asked questions”. The step-by-step implementation model documents could be useful for manufacturers to plan transition to the new Regulations or to determine which steps they still need to take.

Please contact our team if you have any question in relation to the implementation of the Regulations or these new guidance documents.