Effective from DATE, the management (top management) of COMPANY NAME appoints
PRRC name (company name, if external)
as its Person Responsible for Regulatory Compliance (PRRC) according to article 15 of the EU Medical Device Regulation (EU) 2017/745 (MDR). COMPANY NAME acts as a manufacturer of medical devices within the scope of the aforementioned EU Regulation.
The PRRC has to ensure that:
The company gives the PRRC the necessary authority and responsibility to perform the tasks and provides the appropriate resources.
The PRRC ensures permanent and continuous availability in accordance with the contractual agreement.
Place, Date
Management Representative // Person Responsible for Regulatory
Compliance
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