European Parliament Adopts Amendments to Simplify AI Act Implementation (“Digital Omnibus on AI”)
EU Parliament adopts AI Act simplification package. Key changes impact high-risk AI timelines, MDR alignment, and compliance requirements.
European Commission Expands MDR List of Devices Exempt from Clinical Investigations
The European Commission expands the list of implantable and Class III devices exempt from clinical investigations under MDR Article 61. Key regulatory update for manufacturers.
FDA updates SOPP 8412 on product labeling review
FDA releases SOPP 8412 Version 10 detailing labeling review procedures for drugs and biologics under BLA, NDA, and ANDA pathways.
FDA Publishes Updated Guidance on Pyrogen and Endotoxins Testing
FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.
Swissmedic Updates “Formal Requirements” Guidance – Version 20.0 Now in Force
Swissmedic has released Version 20.0 of its “Formal Requirements” guidance, effective 1 March 2026. Learn what pharmaceutical manufacturers need to know about submission formats, documentation requirements and parallel import updates.
Team-NB Raises Concerns Over Proposed MDR and IVDR Revision
Team-NB warns that proposed MDR and IVDR revisions could reduce regulatory scrutiny and create unintended consequences for EU manufacturers, despite improvements in digitalisation and innovation pathways.
Swissmedic Publishes Updated Online Help for the Medical Device Publication Service
Swissmedic has published version 1.2 of its guidance on the Medical Device Publication Service, clarifying how Field Safety Corrective Actions and Field Safety Notices are published and accessed.
Swissmedic Publishes New Guidance on Scientific GMDP Meetings for Establishment Licence Holders
New Swissmedic guidance formalises the process for Scientific GMDP Meetings with Swiss establishment licence holders. Effective January 2026. Download the official document here.
EU MDR/IVDR: Updated List of National Contact Points Released
The European Commission has released the updated list of National Contact Points for the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This essential resource supports compliance for manufacturers, distributors, and stakeholders in the medical device industry. The document includes key updates, such as revised details for Estonia's State Agency of Medicines. Stay informed about the MDR/IVDR landscape, ensure regulatory compliance, and access direct communication with EU competent authorities. Download the latest MDR and IVDR contact points document to stay ahead in the medical device and diagnostic regulation industry.