January 31, 2023

EU Council Accepts Proposal to Postpone MDR Deadline

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

MDCG 2023-2: Guidance on Publishing Notified Body Fees

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

EU Commission Releases Official Proposal to Extend the MDR Transition Period

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

Europe: 2022 Recap & 2023 Look Forward

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 Rev. 1 Update Released: What Has Changed & Why?

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

MDCG 2022-21: Guidance on Periodic Safety Update Reports (PSURs)

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.
December 9, 2022

MDCG 2022-18: Guidance for MDD/AIMDD Manufacturers with Expiring Certificates

The MDCG published new guidance on how to market under MDR Article 97, after an MDD/AIMMD CE certificate expires. Find out who is eligible and how to apply.
December 9, 2022

Breaking: EU Council Supports Postponement of the May 2024 MDR Deadline

The EU Council confirmed they will present a legislative amendment in early 2023 to postpone the May 2024 MDR deadline, and more. Find out more here.
December 6, 2022

EU MDCG 2022-17 Guidance on ‘Hybrid Audits’

The MDCG released a new position paper on 'hybrid audits'. Click here to read the definition and to which situations it applies.