The PRRC is at least responsible for ensuring that the obligations outlined in Article 15 of the EU MDR are satisfied. The PRRC is responsible for: ensuring conformity of devices in accordance with the quality management system, prior to device release is checked. PMS obligations in accordance with Article 10(10). Reporting obligations in Articles 87 to 91. Technical documentation and EU declaration of conformity are drawn up and up to date.
Masqué
YUEN Mick
The PRRC is at least responsible for ensuring that the obligations outlined in Article 15 of the EU MDR are satisfied. The PRRC is responsible for: ensuring conformity of devices in accordance with the quality management system, prior to device release is checked. PMS obligations in accordance with Article 10(10). Reporting obligations in Articles 87 to 91. Technical documentation and EU declaration of conformity are drawn up and up to date.