MDCG2025-6-Interplay Between MDR, IVDR, and the AI Act

MDCG 2025-4 -making available of MDSW apps on online platforms

Team-NB MDR Certification Consensus

MDCG 2019-13 Rev. 1: Understanding the Temporary Sampling Update

MDCG 2024-14-Master UDI-DI for Contact Lenses

MDCG 2024-15- clinical investigation in the absence of EUDAMED

AI in Medical Devices Questionnaire by the German NBs Alliance and Team NB

Gradual Roll-Out of EUDAMED

Supply Interruptions & Discontinuations: The New Information Obligation for Medical Devices and IVDs

MDR Requirements for Legacy Devices: Insights from the Latest MDCG Revision (MDCG 2021-25 Rev. 1)

MDCG 2024-13 - Regulatory status of ethylene oxide

MDR Conformity Assessment Routes:

Sufficient levels of access to data needed to justify claims of equivalence

Guidance on Standardisation for Medical Devices - Rev 1, Published July 2024

Clinical evaluation of orphan medical devices

Risk-Based Statistical Sampling Plan

A Deep Dive into Medical Device Deadlines

The Significance of the EU AI Act for Medical Devices

Person Responsible for Regulatory Compliance, PRRC

MDRChats | Official Trailer