Utvärdering av kravspecifikation vid anskaffning av medicinsk teknik

Sammanfattning: All government controlled business is controlled by the law of public procurement and its five fundamental principles. If these are not fulfilled the procurement is at risk of being subject to a review procedure, which requires both time and money. Therefore it is important to ensure the quality of these processes for contracting authorities such as Region Skåne, especially in conjunction with the introduction of the new medical device regulation, MDR. A part of the procurement process is the development of the requirement specification. Within this document, the requirements are set for the product being procured. In this report, a requirement specification developed by the Medical technology department at SUS in Lund has been evaluated with the purpose of minimizing the risk of a review process. The evaluation has been executed by mapping the new regulation and its transitional provisions. Thereafter court decisions from reviewing procedures have been examined in order to highlight mistakes or where difficulty may rise. Disagreement between the tenderer and the region often occurs in the communication between the parties because of procurement documents open to misinterpretations. From these results the requirement specification was controlled with respect to the technical requirements and a number of solutions were discussed.