Latest Blog Posts
Navigating MDR: Fresh Insights and Updates
EUDAMED: Current Status, Timelines, and Implementation Guide
Co-authored with Preethi Philip Under the MDD 93/42/EEC, the medical device industry lacked a serious level of transparency in the European Union as compared to
Liability of the Authorised Representative Under the MDR
Manufacturers who are not based in the EU have to rely on an Authorised Representatives if they wish to introduce their products there under the
Who Is a Medical Device Distributor and What Should You Be Aware of?
Under the MDD 93/42/EEC, the role of the medical device Distributor was largely unaddressed in the Medical Device legislation within the European Union. Whereas, such
AI Act Meets MDR & IVDR: How Aligned Are They? A Comprehensive Overview
As we prepare for the AI Act to take effect on August 1, 2024—20 days after its publication in the Official Journal on July 12,
Unique Device Identification (UDI) System: An Overview
Unique Device Identification is being implemented on a global scale at a fast pace to allow authorities and economic operators to keep track of all
Understanding the Role of the PRRC in Medical Device Compliance
Regulations are becoming more stringent by the day, with increased safety requirements for medical device manufacturers under the Medical Device Regulation (MDR) and In-Vitro Diagnostic
