Author name: EuMe-adm

Your complete market access overview: now with MDSAP and CE filters Moving beyond myths to facts: Our interactive Regulatory World Map now helps you explore exact market requirements for 20+ countries – filtered by what matters to your strategy. What’s new: MDSAP status filtering: Distinguish between Member, Official Observer, and Affiliate countries CE acknowledgement filter: […]

Global market access is complicated enough without the added confusion of persistent myths. From misunderstood MDSAP requirements to overestimated CE marking reach, these assumptions can derail your expansion timeline and budget. Let’s set the record straight.   ❌The myth: CE mark = instant market access across all European countries ✅ The reality: Whilst the CE

Understanding the critical difference between AI assistance and Regulatory Intelligence   The question we have heard a lot since the webinar As regulatory consultants and Authorised Representative, we’re increasingly asked: “Why can’t we just use ChatGPT or other general AI tools for our regulatory questions? They’re free and seem to know about regulations.” It’s a

This month, the MDCG, together with the Joint Artificial Intelligence Board, published a guidance document on how to handle AI-enabled medical devices under the forthcoming AI Act (AIA) in parallel with existing requirements under the MDR/IVDR. The document introduces the term Medical Device AI systems (MDAIs) and provides a structured overview of how the two

Lisa, we’ve got something new with ISO 11137-1. Let’s dive straight in. What are the main updates in the 2025 revision compared to the previous version? The 2025 version introduces several changes but to me the most important one seems to be the updated normative references. ISO 11137-1 now references ISO 13004 and ISO/ASTM 52628,

Last month, we launched our newest service offering: Computerised System Validation (CSV) – a practical, scalable solution designed to help MedTech companies remain audit-ready and compliant in an increasingly digital and regulated environment. But validation doesn’t stop at go-live. In fact, it’s where the real journey begins. As systems evolve and businesses adapt, so too