Webinar | IVDD to IVDR: Mind the Gap Before You Apply
DNV and MedEnvoy present a one-hour webinar on 9 December 2026 on the IVDD to IVDR transition for Class B and Class A sterile IVD manufacturers preparing for the 2027 milestones.
Resources & News
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European Commission Proposes Regulation to Simplify MDR and IVDR
On 16 December 2025, the European Commission published a legislative proposal to simplify and reduce the burden of the…
MDCG Issues Guidance on Transition from ‘EC REP’ to ‘EU REP’ Symbol on Medical Device Labeling
The European Commission has published the reference of amendment EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European…
EU Classification Guidance Updated: Borderline Manual and MDCG 2021-24
The European Commission published two closely related guidance updates that directly affect how medical devices and in vitro diagnostic medical devices are…
EU Publishes MDCG Guidance on Post-Market Surveillance
As of December 2025, The Medical Device Coordination Group (MDCG) has published MDCG 2025-10, providing comprehensive guidance on post-market…
New EU Guidance on Breakthrough Devices & IVDs
In December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9, a new guidance document…
MDCG 2025-8 and the New Master UDI-DI Requirements
The Medical Device Coordination Group (MDCG) has published MDCG 2025-8, a comprehensive guidance document on…
The EU AI Act and Notified Bodies
As highlighted earlier this year, Team-NB published an updated version of their Position Paper on “European Artificial Intelligence Act (AI ACT)”, it…
New Team-NB Update on Companion Diagnostics Under the IVDR
Team-NB has released a guidance paper on Companion Diagnostics (CDx), providing clarity on how to interpret significant changes to…
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