On 27th June 2022 the Notified Body TÜV SÜD Product Service GmbH issued DIESSE’s first EU Quality Management System Certificate (IVDR), valid for Class B, Class C and Class A Sterile devices

Proudly we announce that the Notified Body TÜV SÜD Product Service GmbH certifies that DIESSE Diagnostica Senese S.p.A. has established, documented and implemented a quality management system as described in Article 10 (8) of the Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices.

On 27th June 2022 it has been issued DIESSE’s first EU Quality Management System Certificate (IVDR), valid for Class B and Class C devices until the next 26th June 2027. Certificate that was integrated on 21 July with the addition of Class A Sterile products, valid until 18 July 2027.

All the products belonging to Class A have been properly CE marked according to EU Regulation 2017/746 (IVDR) within 26th May 2022.

This new regulatory goal represents another important result, which demonstrates our continuous commitment to comply with the highest quality standards.

A goal achieved thanks to the work and professionalism of our Quality department.