March 7, 2023
Today the EU Council adopted the Commission’s proposal. What are the next steps and when is the MDR extension expected to be implemented?
February 16, 2023
Today EU Parliament voted in favor to amend the MDR Article 120 transition provisions, in its first reading. What does this mean, and what are the next steps?
February 14, 2023
New MDCG guidance was issued on MDR vigilance terms & concepts. Find out the key takeaways, including when the reporting 'clock' starts, examples and more.
January 31, 2023
The EU Council has officially accepted the proposal, with no changes. What does this mean in terms of timing to implement the new deadlines for MDR compliance?
January 12, 2023
The MDCG published a guidance document on Notified Body fee transparency, including a table of how fees could be presented to the public. Read more here.
January 6, 2023
Today the EU Commission published its official proposal to extend the transition period for MDR legacy devices. Click to find out the new dates and conditions.
January 4, 2023
Find out what regulatory news you may have missed from the EU Commission and MDCG in 2022 and the upcoming 2023 deadlines for medical devices & IVDs in Europe.
December 20, 2022
MDCG 2022-4, originally published in February 2022, has been updated December 2022. Find out why it was revised, what has changed, and how this impacts you.
December 20, 2022
The MDCG released guidance on Periodic Safety Update Reports (PSUR). Read our overview of who needs one, how to comply and how to find a PSUR template.