Effective from DATE, the management of COMPANY NAME formally appoints
PRRC name (company name, if external)
as the Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of the EU Medical Device Regulation (EU) 2017/745 (MDR). COMPANY NAME operates as a manufacturer of medical devices within the scope of this regulation.
The responsibilities of the PRRC include ensuring:
- The conformity of devices is thoroughly verified in line with the quality management system under which the devices are produced prior to release.
- The technical documentation and the EU declaration of conformity are prepared and maintained in an up-to-date manner.
- Compliance with post-market surveillance requirements as stipulated in Article 10(10) of the regulation.
- Fulfillment of reporting obligations as outlined in Articles 87 to 91 of the MDR.
- In the case of investigational devices, issuance of the statement referenced in Section 4.1 of Chapter II of Annex XV (MDR).
The company grants the PRRC the necessary authority, responsibility, and resources required to execute these duties effectively.
The PRRC commits to maintaining permanent and continuous availability as outlined in the contractual agreement.
Place, Date
Management Representative // Person Responsible for Regulatory Compliance