Latest industry news and developments
The long-awaited Regulation (EU) 2025/1234 now allows manufacturers to provide e-IFUs for all devices intended for professional use. This marks a significant step towards digital documentation in the EU. The article explains eligibility, technical requirements, and the legal framework behind this change.
This update revisits how software should be qualified and classified under MDR, with specific emphasis on Rule 11. The article compares the 2019 and 2025 versions and highlights what manufacturers must now do. It also discusses the broader implications for notified body reviews.
New MDCG documents clarify the roles of platform operators under MDR/IVDR and the AI Act. As software becomes more complex, responsibilities shift to include post-market monitoring and algorithm accountability. Essential reading for developers, distributors and notified bodies.
The European Commission has published updated templates for MIR and FSCA forms, standardizing how medical device incidents are reported. These documents align with Eudamed requirements and evolving expectations from regulators and manufacturers, enhancing transparency and interoperability across the EU.
Switzerland has adopted regulatory changes enabling temporary authorization for high-risk medical devices even without MDR or Swiss approval. The law allows imports from trusted markets (EU, USA, Canada) to address critical supply gaps.
The updated Team-NB guidance on technical documentation provides manufacturers with a comprehensive framework to build MDR-compliant technical files. While non-binding, the document is widely regarded as a reference standard by many notified bodies. Version 3 incorporates updates based on real-world assessments and lessons learned across the sector.
Another inspiring weekend behind us! Our experts from Pure Clinical and MDR Regulator once again led engaging sessions as part of the postgraduate program “Certification and Market Introduction of Medical Devices” at Bialystok University of Technology.
The “IVDR Certification Process – Consensus Document” was developed by Team-NB to provide a unified set of good practices for conformity assessment under IVDR. It reflects not only the regulatory framework but also operational insights gained from notified body assessments during the first years of IVDR implementation. While not legally binding, the document serves as a valuable reference for manufacturers preparing for certification.
The Medical Device Coordination Group (MDCG) has published an updated version of its guidance MDCG 2020-16 rev.4, concerning the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). The revision aims to clarify classification rules in light of emerging technologies and the evolving diagnostic landscape. It includes new examples, refined terminology, and practical advice to support both manufacturers and notified bodies in assigning the appropriate risk class to IVDs.
