FDA Releases Final Guidance on Medical Device Cybersecurity
We explain the requirements of recent FDA cybersecurity guidance.
Is it Too Bold to Refer to this as the Quarter of Data Accessibility?: Second Quarter 2025 Developments
Follow our coverage of medical device regulatory news with this examination of developments from the second quarter of 2025.
European Packaging Waste Legislation Repeals the Directive and Applies in Mid-2026
European medical device Regulation (EU) 2025/40 governing packaging waste was published in January 2025, and most of the requirements apply in August 2026.
Brazil Regulatory Updates
Watch as our regulatory experts discuss Brazil’s evolving medical device regulatory landscape, covering developments in device registration, IVD regulations and UDI compliance in this on-demand webinar.
Current State of UDI in Brazil: Review of RDC 591/2021 and RDC 884/2024
Brazil’s medical device regulator, ANVISA, enacted RDC 591/2021, which legislated the Unique Device Identifier (UDI) requirements for medical devices and IVDs in Brazil. After RDC 884/2024, finally, deadlines are imminent.
Decoding MDCG 2025-6: Interplay Between the MDR/IVDR and AIA
The European Commission has released three new pieces of guidance on medical device software.
EU Releases Guidance on IVD Performance Studies, Finally
The long-awaited Questions & Answers on In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) Performance Studies, MDCG 2025-5 was released by the European Commission on June 18, 2025.
European Revision of Primary Software Guidance (MDCG 2019-11 Revision 1): Small Changes, Meaningful Clarifications
Our regulatory experts clarify the implications of the European Commission’s revision to its guidance on primary software used in medical devices and IVDs.
European Commission issues guidance on making safer apps available
The European Commission has published guidance on making safer apps available to patients and healthcare professionals.
The New Great Britain Vigilance Report Schema Goes Live
On Monday, June 16, 2025, the new Great Britain vigilance report schema goes live in alignment with the timing of the new post-market surveillance regulations coming into force.