Industry News
The latest medical device regulatory news, clinical trials, and market insights
Commission publishes the videos from the third EMDN training, the nomenclature behind every EUDAMED registration
Videos from the third European Medical Devices Nomenclature training were published on 3 August 2026. What the EMDN is, how…
European Commission publishes an updated list of notified bodies’ standard fees
The Commission published a refreshed list of notified bodies' standard fees on 13 July 2026. What the list contains and…
Member States publish their 2025 monitoring reports on notified bodies under MDR and IVDR
The European Commission published Member State summaries of the 2025 annual monitoring and on-site assessment reports for MDR and IVDR…
FDA opens the MDUFA V reauthorisation to public comment as the current authority runs to September 2027
FDA held its public meeting on reauthorising the Medical Device User Fee Amendments for FY2028 to FY2032 on 5 August…
PRRC Perspectives: Tackling Compliance Challenges Under MDR/IVDR
RAPS four hour workshop on how the Person Responsible for Regulatory Compliance functions in organisations of different sizes. 4 CE…
Software as a Medical Device
RAPS interactive workshop for regulatory and quality professionals working on software as a medical device. 12 CE credits. Date: 2026-11-16…
Navigating AI Medical Device Regulations: Global Strategies and Early Engagement
RAPS workshop for regulatory and product development teams working on AI-based medical devices. 4 CE credits. Date: 2026-11-12 Location: Online…
ISO 13485:2016 Addressing Cybersecurity Challenges
RAPS workshop on the gaps between ISO 13485:2016 and current cybersecurity expectations. 2 CE credits. Date: 2026-11-11 Location: Online (Virtual)…
From Alerts to Action: Strategic Regulatory Intelligence
RAPS workshop on turning regulatory alerts into actionable intelligence. 3 CE credits. Date: 2026-11-09 Location: Online (Virtual) Event details and…
EU Medical Device Regulation 2017/745
RAPS workshop on implementing the EU MDR, covering quality system updates and oversight of economic operators. 12 CE credits. Date:…
Navigating Global Medical Device Inspections: Expectations from US, EU, China, Korea, and Japan
RAPS workshop comparing FDA, EU, MDSAP, NMPA and MFDS inspection expectations. 4 CE credits. Date: 2026-10-27 Location: Online (Virtual) Event…
Health Canada’s Medical Device Single Audit Program (MDSAP) Updates 2026
RAPS Western Canada virtual event on the latest developments in the Medical Device Single Audit Program. 1 CE credit. Date:…