December 8, 2023
On 5 December 2023, the EU Commission designated 5 new EURLs. Read here for the implementation date, list of EURLs and more.
December 4, 2023
The EU Commission asks manufacturers and EU ARs to participate in their survey regarding availability of medical devices in the EU. Click here for the link to the survey.
November 30, 2023
Team Notified Body (NB) has scheduled a third IVDR training session for Thursday, February 1, 2024. Find out the agenda, fee and how to sign-up.
November 28, 2023
Team Notified Body issued a press release re: its first MDR training for manufacturers. The Competent Authority for Medical Devices (CAMD) met September 2023 and released a statement.
November 16, 2023
Team Notified Body (NB) has scheduled a third MDR training session for Wednesday, February 7, 2024. Find out the agenda, fee and how to sign-up.
October 26, 2023
The EU Commission published Delegated Regulation 2023/2197 on ‘Master UDI-DI’ for contact lenses. What does this mean and how does it impact you?
October 23, 2023
The Medical Device Coordination Group released MDCG 2023-4 on Medical Device Software (MDSW) – Hardware combinations. Click here for the overview and link.
October 23, 2023
The EU Commission published a new draft EUDAMED timeline on its website. It is now delayed until at least Q2 2027. Read for more details.
October 3, 2023
Team Notified Body is hosting an EU MDR technical documentation file training. Here is your opportunity to take training directly from the Notified Body experts.