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Guidance about PPRC

Guidance on Article 15 - MDR_IVDR PPRC Person Responsible for Regulatory Compliance

Dear Partners,

Please find here attached a guidance recently released by MDCG about the definition and role of a "Person Responsible for Regulatory Compliance" such as defined in Article 15 of MDR / IVDR 2017/745 and 745.


With our best regards,

Christine and Ren├ę

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