IVDR – Declarations

All medical devices placed on the market in the EU and EEA must comply with the requirements of the regulations; Medical Device Regulation (MDR, EU 2017/745, 2021) and In Vitro Diagnostic Device Regulation (IVDR, EU 2017/746, 2022).

For the manufacture and use of self-made IVD equipment, healthcare institutions must publish a declaration stating that the relevant requirements in IVDR Annex I (EU 2017/746), Article 5 (5)) are met for the self-produced equipment. Documentation relating to the development and production of the equipment must be made available to the authorities if requested.

Overview of self-produced IVD equipment manufactured and used in the laboratories of SSHF can be found here:

• Department of Medical Microbiology
• Department of Pathology
• Department of Immunology and Transfusion Medicine