Regulation and Market Access

Get CE Mark Most SaMD is Class IIa or higher—requiring Notified Body involvement. Key Steps: Class-specific routes: This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.

Security = Safety Under EU MDR, cybersecurity is a General Safety and Performance Requirement. Failure to secure software is a patient safety risk. Technical Steps: GDPR Considerations: This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.

To enter the EU market, your SaMD must be developed under a Quality Management System (QMS) that complies with ISO 13485. What You Need Best Practices Cybersecurity Integration Use MDCG 2019-16 as a guideline for secure development. Cybersecurity is considered a safety issue under EU MDR, it is not just IT hygiene. Learn More: This…

EU MDR’s Annex VIII, Rule 11 determines how software is classified: What Determines the Class? Example: References: This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.

Software as a Medical Device (SaMD) refers to software intended for medical purposes that performs these functions without being part of a hardware medical device. Under the EU MDR (Regulation 2017/745), it’s officially termed Medical Device Software (MDSW). Key Definitions MDSW under EU MDR aligns closely with the global SaMD concept defined by IMDRF. A…

The MedTech landscape is evolving fast, and in 2025, the race to win in the market is no longer just about innovation. It’s about **how you commercialize**, how you adapt to shifting sites of care, and how you create measurable value for buyers. A timely example? Cambridge-based CMR Surgical is reportedly exploring a $4B sale…

In July 2025, the U.S. FDA issued a warning letter to Whoop, Inc. for marketing its Blood Pressure Insights (BPI) feature without regulatory clearance. The agency concluded that Whoop’s sleep-based blood pressure estimation feature qualifies as a medical device, not a general wellness tool. This finding has implications far beyond one wearable band. New to…

Digital marketing has become a cornerstone of successful go-to-market strategies in the MedTech industry. Yet, marketing medical devices presents a distinct set of challenges, from navigating complex regulatory environments to building trust with clinical and procurement audiences. This guide examines the unique aspects of medical device digital marketing, its evolution in 2025, and the key…

I. Introduction: Europe’s Ascendance in MedTech Innovation The landscape of healthcare is undergoing a profound transformation, driven by relentless innovation in medical technology. At the forefront of this evolution stands the MedTech Innovator (MTI) program, globally recognized as a premier accelerator for breakthrough medical device, digital health, and diagnostic companies. Its rigorous selection process, which…

Even with the right product, market, and team — many MedTech startups fail. And the reasons often come down to avoidable commercialization mistakes: misjudging the buyer, skipping regulatory nuance, or assuming your tech will sell itself. This final post in the Scaling MedTech: From Product to Market series lays out the most common missteps in…