Software as a Medical Device (SaMD) is one of the fastest-growing segments in the medical device industry, yet classification and regulatory pathways differ significantly between the US FDA and the European MDR systems. This focused 90-minute webinar provides a systematic comparison of SaMD classification approaches — from the IMDRF framework to FDA’s risk-based categorization and EU MDR Rule 11 — so participants can correctly classify their software and choose the right pathway in both jurisdictions.

The course covers the IMDRF SaMD framework and global harmonization, FDA’s approach to software regulation (including Digital Health Software Precertification Program developments and Clinical Decision Support exemptions), and EU MDR requirements with special attention to Rule 11 and MDCG guidance (MDCG 2019-11 and MDCG 2020-1). It compares 510(k), De Novo, and PMA pathways against EU conformity routes and the role of Notified Bodies.

Emphasis is on practical classification exercises, pathway-selection decision trees, documentation strategies for dual submissions, and timeline and resource planning — along with common pitfalls and how to avoid them. Attendees receive presentation materials and a certificate of completion.

Agenda at a glance:

• Introduction to SaMD regulation — SaMD vs. SiMD, the IMDRF framework, and recent guidance updates.
• FDA SaMD classification and pathways — risk-based classification, 510(k)/De Novo/PMA, CDS exemptions, Digital Health Center of Excellence, and pre-submission strategy.
• EU MDR classification for software — Rule 11 deep dive, MDCG 2019-11 and 2020-1, Notified Body role, and technical documentation.
• Comparative analysis and strategy — side-by-side outcomes, dual-submission documentation, timelines, and pitfalls.
• Practical case studies — classification exercises, a pathway-selection decision tree, and Q&A.

After this webinar, attendees will be able to answer -

• How does the IMDRF SaMD framework classify software, and how is it used globally?
• How does FDA apply risk-based categorization, and when do Clinical Decision Support exemptions apply?
• How should EU MDR Rule 11 be applied correctly to classify software?
• How do the 510(k), De Novo, and PMA pathways compare with EU conformity routes?
• What classification errors most often delay market access, and how can they be avoided?
• How do you build a coherent dual-market regulatory strategy for a software product?

This webinar benefits the following agencies -

The session compares US FDA and EU MDR requirements for software, referencing the IMDRF SaMD framework, EU MDR Rule 11, and MDCG guidance documents (2019-11 and 2020-1). It is relevant to organizations developing or marketing medical device software in the US and EU.

Who should attend?

This webinar benefits professionals responsible for classifying and complying with software products in regulated markets, including:

• Regulatory Affairs professionals working with software products
• Product managers of digital health solutions
• Quality managers responsible for SaMD compliance
• Software development leads entering regulated markets

Startup founders developing medical software