IVDR – Declarations of conformity
In Vitro Diagnostic Device Regulation (IVDR) and in-house manufacture of medical devices.
All medical devices placed on the market in the EU and EEA must meet the requirements of the regulations: the Medical Device Regulation (MDR, EU 2017/745, 2021) and the In Vitro Diagnostic Device Regulation (IVDR, EU 2017/746, 2022).
For the manufacture and use of in-house IVD equipment, healthcare institutions are required to publish a declaration of conformity stating that the relevant requirements of IVDR Annex I (EU 2017/746), Article 5(5), are met for the in-house manufactured equipment. Documentation relating to the development and manufacture of the equipment must be made available to the authorities upon request.»
An overview of in-house manufactured IVD equipment produced and used by the laboratories at SSHF can be found here: