Where Capital Flows Investors favor: Valuation Benchmarks: Learn more at Scaling MedTech: From Product to Market This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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…
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…