February 22, 2024

Team NB Position Paper: Proposal to Reclassify SARS-CoV-2 (COVID) in vitro Diagnostic Devices

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: Process & Timing to Add, Amend, Obsolete New EMDN Codes

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.
February 6, 2024

MDR Transition Deadline of 26 May 2024: What is a “lodged” application with the Notified Body?

By May 26, 2024 MDD/AIMDD devices must have ‘lodged an application’ with a Notified Body, or they lose access to the market. Find out exactly what that means.
February 2, 2024

Team Notified Body: New MDR Training Session Available for April 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

New: MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Templates

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: Further Delay to IVDR, New Reporting Obligation & New EUDAMED Deadline

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

EU Commission Publishes Language Translation Requirements under the MDR & IVDR

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

EU Commission: New Dashboard Monitoring Availability of Medical Devices on the EU Market

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: Clinical Investigation Exemptions & Claiming Equivalence

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.