About New Criteria Consulting

New Criteria Consulting focuses on the Medical Device and In-vitro Diagnostic Device Sector and aims to aid manufacturers and distributors to enter or maintain their presence in the “European Market” by ensuring their adaptation to the new European Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
After the adaptation of MDR and IVDR, the manufacturers are now required to act under the guidelines of these two regulations in order to market their products in Europe. With our team of experienced specialists, we guide our customers through their adaptations to the new regulations of the European Union on medical and in vitro diagnostic devices.