February 2, 2024
Team Notified Body has scheduled another MDR training session for Monday, 29 April 2024. Click here for the agenda, fees, and how to sign-up.
January 31, 2024
The MDCG issued guidance harmonizing vigilance reporting for serious incidents, Periodic Summary Reports, and trend reporting. Click here for the overview and link.
January 23, 2024
New Commission Proposal to 1) further the delay the IVDR for 'legacy' devices 2) require manufacturers to report disruption to device supply, and 3) new EUDAMED "roll-out" deadlines.
January 18, 2024
New EU Commission resource: consolidated Language Translation Requirements under the MDR/IVDR. Find out what’s included, what’s excluded, and get the links.
January 9, 2024
The European Commission created a new dashboard, providing an overview of the availability of medical devices & IVDs on the European market.
January 4, 2024
MDCG 2023-7 on clinical investigation exemptions & level of data needed to claim equivalence, was newly published in December 2023. Click here for the overview.
January 3, 2024
MDCG 2019-07, on the Person Responsible for Regulatory Compliance (PRRC), was originally published in June 2019. It has now been revised (December 2023). Read about the changes here.
December 20, 2023
MDCG 2021-27 has been revised to add six new Q&As and update three existing Q&As. For the link and what's new, click here.
December 18, 2023
Team NB released a new position paper on medical device lifetime: common understanding of the term, how to determine lifetime & recommendations to manufacturers. Click here to read more.