Swissmedic has published swissdamed Business Rules Version 4.0, introducing new Master UDI-DI requirements, UDI registration rules, and data management obligations for medical device manufacturers in Switzerland.

MedTech Europe has published new recommendations for the MDR/IVDR revision, calling for a more proportionate regulatory framework, support for innovation, and improved access to in vitro diagnostics across Europe.

Team-NB has published Version 2 of its MDR Certification Process Consensus Document, providing detailed guidance on pre-application, application, conformity assessment and surveillance activities for medical device manufacturers under EU MDR 2017/745.

The European Commission has released Version 3 of its Living Guidelines on the Responsible Use of Generative AI in Research. Learn what the new recommendations mean for medical device manufacturers, clinical evaluation, data protection and research activities.

MedTech Europe responds to the EU Cybersecurity Act consultation, highlighting key implications for medical device and IVD manufacturers, including certification, vulnerability management, and supply chain security.

A new legal opinion analyses the European Commission’s proposed MDR Article 50, highlighting potential impacts on notified bodies, SMEs, certification costs, and conformity assessment access.

ANVISA’s new 2024–2025 GCP inspection report highlights critical findings in clinical trials, data integrity, electronic systems, SOPs, and investigational product management. Learn what manufacturers and sponsors should review.

Swissmedic highlights the updated MIR template version 7.3.1 for MDR/IVDR vigilance reporting. Learn how the new requirements impact medical device and IVD manufacturers.

The European Commission released version 2.27.0 of the EUDAMED UDI Devices User Guide, clarifying UDI registration, EMDN management, packaging levels, and lifecycle updates under MDR and IVDR.

The Australian TGA has updated its guidance to recognise UK Approved Bodies as comparable overseas regulators, potentially simplifying ARTG submissions for medical device and IVD manufacturers.

The European Commission has adopted Regulation (EU) 2026/977 introducing new MDR and IVDR rules for notified body timelines, quotations, transparency and re-certification activities.

Swissmedic has updated the swissdamed Actors User Guide (v2.0), introducing AGOV login migration updates, mandate transfer functionality, and clarified actor management requirements for medical device manufacturers and authorised representatives in Switzerland.

The EU Council and Parliament reached a provisional agreement to simplify the AI Act, including delayed deadlines for high-risk AI systems and clarifications for manufacturers.

The European Commission has adopted Implementing Regulation (EU) 2026/977, introducing new conformity assessment requirements for notified bodies under the MDR and IVDR.

MedTech Europe has published its position on the MDR/IVDR revision, supporting simplification measures while warning about new burdens for manufacturers, AI compliance challenges, cybersecurity reporting, and single-use device reprocessing.

TEAM-NB releases Code of Conduct v5.2 for MDR/IVDR Notified Bodies. Discover key changes and how they impact medical device manufacturers.

Team NB explains when manufacturers can rely on non-clinical data under MDR Article 61(10) and highlights common compliance pitfalls.

Team-NB releases Version 4 guidance on MDR technical documentation. Key requirements, common pitfalls, and implications for medical device manufacturers.

Swissmedic releases updated guidance on medical device software (MDSW), covering qualification, classification, and regulatory requirements under MDR/IVDR.

MDCG publishes Revision 2 of EMDN guidance, clarifying code assignment, updates, and EUDAMED requirements under MDR and IVDR.