Hi everyone,
the new MDR had defined new responsibilities in Articel 15 of MDR 2017/745, "responsible person for regulatory compliance".
Is this a different person than required in ISO 13485 (Management Representative)?
From my understanding the MDR requires someone who makes sure the product is compliant and approves the certification procedures, whereas the person required in ISO 13485 is someone who takes the whole responsibility of the QMS and reports to the top management.
Thank you
Best,
Daliane
the new MDR had defined new responsibilities in Articel 15 of MDR 2017/745, "responsible person for regulatory compliance".
Is this a different person than required in ISO 13485 (Management Representative)?
From my understanding the MDR requires someone who makes sure the product is compliant and approves the certification procedures, whereas the person required in ISO 13485 is someone who takes the whole responsibility of the QMS and reports to the top management.
Thank you
Best,
Daliane