Understanding transitional Period in MDR
MDR and IVDR have been published in April 2017, entered into force into 2017, and will become fully applicable respectively in spring 2021 and spring 2022. The implication of this is that a transitional period has been envisaged for MDR and IVDR manufacturers to go through to get ready to fully comply with the Regulation. This document provides guidance on how to make best use of the transitional period.
This MDR Implementation Tool was updated in May 2020 following the new Regulation amending certain provisions of the MDR.