Session 4, Day 2 MedTech20: EU Medical Device Regulation (MDR) and BREXIT Update.
Key points:
Due to COVID-19 priorities, the European Parliament has postponed the deadline for full enforcement of the MDR by one year.
The new legislation is complex and detailed; guidance documents are being issued; expert scientific panels are being set up; and companies are currently focusing on getting their quality systems and files up-to-date.
Legacy products (under MDD) need a transition plan in place now, and not wait until 2024. Post 2024 it will not be possible to commercialize products using MDD.
TGA and MTAA members are collaborating in preparation for the implementation of MDR in Australia.
Thanks to the speakers: George Faithfull, Tracey Duffy, Jesus Rueda Rodriguez, Oliver Bisazza, Erik Hansson