MDR/IVDR Declaration of Interest

As a notified body, we perform all our testing, certification and conformity assessment activities and the controls associated therewith on the basis of our Testing and Certification Regulations as a third party applying the highest degree of professional integrity and the requisite competence.

To ensure independence, impartiality and objectiveness, we only provide testing and certification services under the scope of the MDR and IVDR after submission of an application for conformity assessment. With respect to potential conformity assessment, and as prerequisite of the MDR and IVDR, we do not offer consulting services either to economic actors or to our customers other than exchange of technical information and regulatory guidance.

Our testing and certification services are offered to all interested parties after detailed review of the submitted applications and without preference or discrimination.

We always ensure impartiality as an important and exclusive element; in particular, we make sure that our impartiality is not jeopardised by any commercial, financial or private interests nor by any other pressure.

Our employees make all testing and certification decisions solely in line with the legal or regulatory, professional or normative requirements and follow the TÜV SÜD Code of Ethics.

We guarantee the impartiality of the notified body, the top-level management and the assessment personnel. The level of remuneration of the top-level management and assessment personnel of the notified body and of any subcontractors involved in assessment activities does not depend on the results of the assessments. The notified body hereby makes the declaration of interest of its top-level management publicly available.

TÜV SÜD Product Service GmbH 

Signed: Walter Reithmaier 

Signed: Dr Patrick van Welij