Selecting a notified body for software as a medical device is one of the earliest decisions that materially affects a CE marking timeline, and it is made under conditions that differ from those facing a hardware manufacturer. A notified body is a conformity assessment body designated by an EU member state under Regulation (EU) 2017/745 […]
For engineering leads and software architects building Software as a Medical Device, regulatory compliance is often perceived as an administrative burden that happens at the end of the development cycle. When a SaMD software architecture is created without considering international lifecycle standards, primarily IEC 62304, ISO 14971, and FDA pre-market guidelines, the resulting technical debt […]
Mental health products often start with a simple idea. A team wants to help people track their mood, understand stress, build healthier habits, or access structured self-help content. At that stage, the product may look like a wellness app. But the regulatory question changes when the product starts to assess symptoms, guide decisions, recommend interventions, […]
Large Language Models are changing how MedTech teams work, and one of the most practical areas of impact is SaMD regulatory documentation. For companies developing Software as a Medical Device, documentation is not just an administrative task. It is a core part of the product’s compliance story, the evidence trail behind key decisions, and often […]
For many medical device manufacturers, EUDAMED used to sit somewhere near the end of the regulatory checklist. Important, but not always urgent. Now, that has changed. As of 28 May 2026, the first four EUDAMED modules became mandatory: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. The European Commission confirmed this following […]
Here is a scenario that plays out more often than anyone in this industry likes to admit. A founding team spends four years developing a device. They run the clinical study. They file the 510(k). They get cleared. They hire their first two sales reps, set up shop at a major conference, and start calling […]
The EU MDR 2026 amendments are the most consequential shift in European medical device regulation since the original EU MDR 2017/745 entered application. For global Pharma and MedTech organizations developing Software as a Medical Device (SaMD) and Digital Therapeutics (DTx), these amendments do not simply update compliance requirements; they fundamentally changed product strategy, investment priorities, and speed […]
Introducing artificial intelligence (AI)-based medical devices to the European market demands more than cutting-edge technology. Achieving compliance with the EU Medical Device Regulation (MDR 2017/745) hinges on a comprehensive understanding of the regulatory landscape governing product safety, clinical performance, and market approval. Notably, the clinical data requirements necessary for CE marking represent some of the […]
Why UDI matters in the European market Medical device companies today face an increasingly demanding regulatory environment in Europe. With the full enforcement of the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746), one topic has risen to the top of every compliance agenda: UDI registration and device traceability. These […]
The implementation of IEC 62366-1 usability engineering is essential for developing Software as a Medical Device (SaMD) and Digital Therapeutics (DTx). Systematic application of usability engineering principles enables these digital health products to fulfill stringent regulatory standards, significantly enhance patient safety, boost user engagement, and optimize therapeutic outcomes. A structured IEC 62366-1 approach ensures that […]
