Person Responsible for Regulatory Compliance

Medical Device

5/12/2022

Training for background, tasks and responsibilities of PRRC:

• Legal framework according to MDR Article 15
• Responsibilities, job description and assignment
• Conformity of devices produced under QMS
• Technical documentation and DoC
• PMS
• Reporting of serious incidents, FSCA and FSN
• Issuing the statement for investigational devices
• Definition of trends and reporting of trends
• Sharing and delegation among several persons
• Guidance by MDCG 2019-7, MDCG 2021-25

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