Laboratoires CHEMINEAU

ensuring that (see article 15 of REGULATION (EU) 2017/745): -conformity of the devices is appropriately checked before a device is released, -technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; -PMS obligations are complied with in accordance with Article 10(10); -reporting obligations referred to in Articles 87 to 91 are fulfilled; -in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued

Back up PRRC in case of absence of the permanent PRRC, ensuring same responsibilities as permanent PRRC (see above and article 15 of REGULATION (EU) 2017/745)