National Centre for Nuclear Research

medical accelerators in the range: -the conformity of the devices is appropriately checked, in accordance with the quality management system, before a device is released; -the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; -the post-market surveillance obligations are complied; -the reporting obligations are fulfilled; -in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

medical accelerators in the range: - the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; - the post-market surveillance obligations are complied with in accordance with Article 10(10); - the reporting obligations referred to in Articles 87 to 91 are fulfilled;

accessories for radiopharmaceuticals in the range: -the conformity of the devices is appropriately checked, in accordance with the quality management system; -the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; -the post-market surveillance obligations are complied; -the reporting obligations are fulfilled; -in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.