The new MDCG 2025-6 guide, published in June 2025, clarifies the joint application of the AI Act and the European MDR/IVDR regulations for medical devices and IVDs with artificial intelligence systems. The document addresses classification, risk management, life cycle, technical documentation and post-market monitoring. Smart MDR supports manufacturers in integrating these requirements into their quality management system and preparing for audits.

MDCG 2021-12 Rev.1 FAQ provides a detailed explanation of the European Medical Device Nomenclature (EMDN), which is an essential resource for ensuring the compliance of medical devices and IVDs in the context of the European Union's MDR and IVDR regulations. With the January 2025 revision, this document guides manufacturers on how to correctly assign EMDN codes to their devices in EUDAMED. In addition, it clarifies aspects of the hierarchical structure of the nomenclature, the use of alphanumeric codes, and the annual nomenclature update process.

The revised Preliminary Assessment Review (PAR) templates under the MDR (Regulation (EU) 2017/745) bring critical updates for Notified Bodies and the medical device industry. Published by the Medical Device Coordination Group (MDCG) in January 2025, the revisions focus on simplifying regulatory processes, including the removal of redundant sections and enhancing annexes for detailed guidance. These updates are essential for companies aiming for regulatory compliance, CE marking, and alignment with European medical device regulations.