Upcoming Seminars

Sixty days earlier: MDSS Webinar fuelling your EUDAMED readiness check and action plan, including:

• Internal EUDAMED assignments
• Actor registration and permissions
• Required device data
• Registration workflow
• Time required for registering x devices
• Common obstacles
• Priorities in case not all devices can realistically be registered before deadline

Insights are based on numerous successful EUDAMED implementation/assistance projects for our clients.  

Not started your EUDAMED project yet?
Start today and reach out to us for immediate support. Use the September webinar for an intermediate status check.

Already confident your company is prepared/completed all actions?
Use the webinar as a reality check and gain assurance that no critical aspect has been overlooked.

Do not lose compliance due to a missed deadline. 
Join us in September and turn the remaining 60 days into a focused action plan, before November turns pressure into non-compliance.

Software moves at a fundamentally different pace than the hardware in a medical device. A change that takes a software team an afternoon to build and ship can take a Notified Body months to review. What constitutes a substantial change under Regulation (EU) 2017/745 (EU MDR) varies among stakeholders, and guidance is opaque. For manufacturers building AI-enabled, adaptive, or rapidly iterating software medical devices, the gap between development velocity and regulatory cadence has become one of the defining challenges of bringing a product to market and maintaining it in Europe.

This session, presented by the Notified Body Scarlet, unpacks what the EU MDR actually requires for the change management of Software as a Medical Device, where the friction points lie, and what good looks like in practice. We’ll work through the substantial change framework requiring pre-approval, examine why SaMD breaks the traditional change-control model, and explore practical strategies, from change classification discipline to release batching, that high-performing teams use to ship faster without losing compliance. Finally, we’ll look ahead to the potential of Predetermined Change Control Plans (PCCPs): how the FDA framework works today, what the EU is signalling through the AI Act, and how manufacturers can start preparing now for a PCCP-enabled future in Europe.