With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the
regulatory framework for medical devices and in vitro diagnostic medical devices
(IVD) has changed significantly. The main objectives of these two regulations are to
“establish a robust, transparent, predictable and sustainable regulatory framework for
medical devices and in vitro diagnostic medical devices which ensures a high level of
safety and health whilst supporting innovation”.
Five years have passed since their adoption and the system is being implemented
including the development of the joint assessment process for designation of notified
bodies, designation of expert panels, publication of harmonised standards as well a
large number of guidance documents seeking to help economic operators to comply
with their obligations under the Regulations…
