The PRRC (EU MDR art. 15 requirements) is responsible for - the conformity of the under which the devices are manufactured, before a device is released - the technical documentation and the EU declaration of conformity - the post-market surveillance obligations are complied - Article 10(10) - the reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled - in the case of investigational devices the statement referred to in Section 4.1 of Chapter II of EU MDR Annex XV is issued