Without providing a full and comprehensive market vision, but based on feedbacks from GMED teams, there is a common denominator at play: heterogeneity in the level of anticipation and preparation of manufacturers for the new Regulation (EU) 2017/745 (MDR).
Only a limited number of market players have sufficiently anticipated this major regulatory, organizational, and financial turning point by implementing a transition plan in accordance with MDR requirements, with the aim of continuing to market their medical devices (MD) in Europe.
Other manufacturers, and there are many of them, have chosen to wait for the end of the grace period to start transitioning to MDR, running the risk of product certification lapse fueling a potential market disruption. Indeed, as certification timelines are longer under the new regulation compared to those under the directive, some applications for certification will not be locked in MDR certification before the end of the grace period.
In order to help you better anticipate and prepare for your transition to the MDR, here is some feedback from GMED teams who have monitored the situation over the past 15 months. Highlighting the points to look out for during the various phases of the certification process under this new regulation.