Swissmedic Publishes “Good Practice for Materiovigilance in Hospitals” (GPMV-Spital)
Swissmedic releases GPMV-Spital, a new framework for materiovigilance in hospitals. Understand the impact on medical device manufacturers and post-market surveillance.
European Commission publishes results of 18th Notified Body survey under MDR and IVDR
Latest European Commission data shows MDR and IVDR application volumes, certification timelines, and submission quality based on the 18th Notified Body survey (October 2025 data).
MedTech Europe Calls for Greater Alignment in EU Digital Omnibus Proposals
MedTech Europe highlights key challenges in the Digital Omnibus, including AI Act timelines, GDPR updates, and Data Act implications for manufacturers.
Swissmedic publishes updated guidance on Systems and Procedure Packs (SPP)
Swissmedic updates guidance on systems and procedure packs. Key obligations, CH-REP requirements, and impact for medical device 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 Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
The FDA has issued final guidance on medical devices with indications associated with weight loss, outlining regulatory expectations for clinical studies, non-clinical testing, and benefit-risk evaluation.
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.
FDA Updates Guidance on Clinical Decision Support (CDS) Software for Healthcare Professionals
New FDA guidance clarifies which Clinical Decision Support software functions are not considered medical devices. Key updates affect software developers and manufacturers.
Kickstart your 2026 Regulatory Strategy with Smart MDR
Did you miss our holiday announcement? Don't worry—there is still time to accelerate your market entry in 2026 with an exclusive advantage. Regulatory compliance shouldn't be a barrier to innovation. At Smart MDR, we are extending our special support for Startups to ensure your medical device, IVD, or SaMD hits the European market faster and more efficiently.