Postponement of the introduction of MDR
The full implementation of the updated Medical Device Regulation (MDR) has been reassessed by the European Commission due to the current corona pandemic. It was decided to postpone the date of entry into force to 26 May 2021. Until this date, the current legal situation will therefore continue to apply. However, the subsequent transition period, the so-called “Grace Period”, is causing uncertainty among many manufacturers and developers of medical technology, as the new planning suddenly reduces the period from the originally estimated four years to only three years. In this article, we explain what effects this has on approval, what exceptions there are for product certificates and what manufacturers should bear in mind when certifying products for certain dates.