Update of the Q&A on the extension of the MDR transitional period and removal of the ‘sell off’ periods

On July 18th, 2023, the European Commission released an update Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

This update gives more clarity on derogations using of Article 59 MDR or Article 98 MDR and conditions to be fulfilled to benefit from the extended MDR transition period.