Roboscreen GmbH

Responsible for reporting obligations according to Articles 82 to 86 IVDR

Responsible that the technical documentation and the EU declaration of conformity are created and kept up to date. Responsible for providing the signed declaration referred to in Annex XIV Section 4.1 IVDR (see Chapter 4 for explanation) for devices for performance studies to be used in the context of interventional, clinical performance studies or other performance studies involving risks for the subjects.

Responsible that the verification of the conformity of the products before release is carried out in an appropriate manner according to the quality management system under which the products are manufactured and tested. Responsible for fulfilling the post-market surveillance obligations under Article 10(9).