Regulation is not background noise. In European life sciences, it is part of the commercial model.
This section tracks the policy, access, compliance, and approval changes that shape adoption, timing, and strategic options.
Staying Compliant Post-Launch Post-market surveillance (PMS) is required for all devices. Requirements: For Class IIa+, submit PSUR every 1–2 years. This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
CE Mark ≠ Reimbursement Each EU country has its own reimbursement process. Highlights: – Germany (DiGA): Fast track, 12-month provisional access – France: Multiple programs (ETAPES, PECAN) – UK: NICE approval + local commissioning (ICBs) Evidence needs differ, it can be Randomized Controlled Trials (RCTs) or real-world evidence depending on system. Learn more on Scaling…
MDR Requirements SaMD must show: Documentation: Use real-world evidence, literature, or clinical studies. This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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…