April 23, 2024
New guidance on the Investigator’s Brochure contents, an integral part of clinical investigation documentation. Click here for a summary of requirements and a link to the Word version checklist.
April 16, 2024
MDCG 2022-9 on Summary of Safety and Performance requirements under the IVDR has been updated. Find the link to MDCG 2022-9 Rev.1 and an overview of the changes.
April 15, 2024
Team Notified Body (NB) has scheduled a fourth IVDR training session for Wednesday July 3, 2024. Find out the agenda, fee, and how to sign-up.
April 12, 2024
New EU Commission dashboard on reprocessing of single-use devices under the MDR 2017/745. Find out which Competent Authorities allow it, restrictions, and more.
March 14, 2024
New MDCG guidance Clinical Investigation Plan contents has been issued. Plus, a Word version Clinical Investigation Plan Synopsis Template. Click here for the overview and links to each.
March 11, 2024
Eight new standards have been harmonized under the EU MDR and three newly harmonized under the EU IVDR. Click here for the full list and links.
March 7, 2024
Team NB has announced a 6th MDR training session for June 2024. The April 2024 training is now fully booked. Click here for the training details and link to sign-up.
February 22, 2024
Team Notified Body has proposed reclassifying SARS-CoV-2 (COVID) IVD devices. Find out the proposed new classification and consequences for manufacturers.
February 7, 2024
MDCG 2024-2 outlines the process of reviewing new EMDN code requests. Find out how they are processed, the timing, and the steps to request a new EMDN code.