Person Responsible for Regulatory Compliance

Medical device

5/12/2022

Legal framework according to MDR Article 15,

Responsibilities of the responsible person,

Conformity of devices produced under the quality management system,

Technical documentation and Declaration of Conformity,

Post-market surveillance system,

Reporting of serious incidents, field safety corrective actions and field safety notices,

Issuing the statement investigational devices,

Definition of trends and reporting of trends,

Possibilities of implementation: Job description,

Sharing and delegation of responsibility or duties among several persons,

◼ Provisions on fines according to German law (MPDG) ◼ Guidance by MDCG 2019-7, MDCG 2021-2

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