192 Plaintiffs Claim EUR 36 Million! The PFAS Storm Is Spreading to EU and US Packaging Compliance
A recent PFAS story from Europe has attracted wide attention. In the “Chemical Valley” south of Lyon, France, 192 residents
Regulatory News
Global medical device regulatory updates and registration guides
Key Points in Implementing Medical Device UDI
In March 2026, the National Medical Products Administration (NMPA) issued two new announcements on the implementation of the Unique Device
EU MIR Manufacturer Incident Report Form v7.3.1: What’s New
The European Commission / Medical Device Coordination Group (MDCG) has published the new MIR (Manufacturer Incident Report) form v7.3.1, which
MDR (Regulation (EU) 2017/745) Amending Acts
In March 2026 the EU issued two acts in quick succession that relax clinical investigation and technical documentation assessment requirements
Thai FDA Medical Device Registration
Thailand’s imports of medical devices are growing noticeably each year, which fits well with the overseas expansion plans of Chinese
The Interplay Between the MDR/IVDR and the AI Act (AIA)
In June 2025 the EU Artificial Intelligence Board (AIB) and the Medical Device Coordination Group (MDCG) jointly published the guidance
EU Regulations on Clinical Trial Design for AI-Assisted Detection Products
Clinical trial design is the most central and most challenging part of compliance for AI-assisted detection products in the EU.
Introduction to EU AI Medical Device Compliance
The compliance route for AI medical devices entering the EU market rests on the coordinated regulation of the MDR/IVDR and
Medical Device Software Terminology in the EU and the US
The EU and US terminology systems for medical device software both use the core definitions published by the International Medical
GDPR vs the EU Data Act: Similarities and Differences
Regulation (EU) 2016/679, the General Data Protection Regulation (GDPR), has applied in full since 25 May 2018. Most provisions of