In the European Union, there are different regulatory requirements for clinical trials of medicinal products, clinical investigations of medical devices, and performance studies of IVDs.…
Poland: MDR & IVDR national implementing laws
Upon the publication of the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR), Poland has taken steps to establish…
MDR & IVDR national implementation: Croatia
Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Devices Regulation (IVDR) 2017/746 are mainly the Act on the…