TEGOS represented OÜ Balti Intermed before the Public Procurement Review Committee in a challenge concerning West Tallinn Central Hospital’s procurement of a digital pathology whole slide imaging (WSI) scanner.
The case involved a complex intersection of public procurement law, the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and healthcare liability rules. The dispute required a detailed analysis of IVDR conformity assessment principles, the scope of issued certificates and the application of European Commission Regulation 2024/1860 within the diagnostic workflow.
The challenge addressed six procurement conditions, including slide glass specifications, magnification requirements, the scope of IVDR certification, a self-validation requirement, a linear camera award criterion and the equivalence of certification requirements. The Public Procurement Review Committee upheld all six grounds of challenge and ordered the contracting authority to amend the contested conditions to ensure compliance with applicable law.
The decision is significant beyond the parties involved, as it contributes to the development of procurement practice regarding the principle of technological neutrality in medical device procurements. It also provides guidance on how contracting authorities should take account of evolving regulatory requirements when drafting technical specifications in healthcare-related tenders.
