on the scope of IVD and laboratory instrument supplier documentation in the context of requirements
ČSN EN ISO 15189 ed. 3:2023 and Regulation (EU) 2017/746 (IVDR)
The Czech Institute for Accreditation, the Czech Association of Manufacturers and Suppliers of In Vitro Diagnostics and interested professional societies of the Czech Medical Association of J. E. Purkyně have agreed on a position statement following up on previous documents from 2015 and 2017. It responds to the revision of the ISO 15189 standard and the entry into full force of the IVDR Regulation. It is intended as a recommendation for Medical laboratories and their suppliers in fulfilling legislative and regulatory requirements regarding laboratory equipment, reagents and related requirements.