MDR: What Changes When You Need a CE Mark?
A practical breakdown for health tech founders navigating EU MDR for the first time.
You have a product vision. You have a market. Now you need a CE Mark. This webinar walks you through what that actually means for your development process: how responsibilities are split, what documentation needs to exist, and what has to be in place before an auditor walks in.
Why CE Mark Is More Complex Than It Looks
Most founders know they need a CE Mark to sell in the EU. What they underestimate is how much of the certification burden shapes the development process from day one.
EU MDR does not just regulate the device itself. It regulates how the device was designed, documented, built, and tested. Every library version, every architectural decision, every design change needs to be traceable. And when something is not documented, it is assumed it was not done.
This webinar gives you a clear picture of what changes in your project once MDR is on the table, so you can plan for it before it becomes expensive.
.avif)
What's Inside
Your MDR Journey as a Manufacturer
What you need to do to reach CE Mark as the manufacturer of record: QMS setup, Notified Body engagement, and how your development partner fits into that process.
Intended Use and Device Classification
How your intended purpose statement determines device class, software safety level, applicable standards, and whether clinical trials are required. Two real examples from wearables-based applications.
Technical Documentation: What Needs to Exist
The full breakdown of documentation required for an MDR audit: Delivery Plan, Software Architecture, Software Description, Design, Verification and Validation, and Traceability. What you own and what your development team delivers.
Risk Management and FMEA
How risk analysis works in an MDR project, how FMEA is structured, and why it is an ongoing process that runs through development and maintenance, not a one-time deliverable.
Change Management Under MDR
Why continuous deployment is not compatible with regulated products. How every accepted requirement change triggers a formal assessment, documentation update, and regression test cycle.
Audits: What to Expect
How MDR audits work, what the Notified Body can ask for, and what process documentation needs to exist before the audit starts.
What Founders Get Wrong Before They Start
01
02
03
04
Who Needs This Recording
CTOs and Engineering Leaders
You are the manufacturer of record. Before you sign a contract with a development team, understand what MDR actually requires from your side and what questions to ask before the build starts.
Product Teams and Founders
You will own User Needs and Software Requirements. This webinar explains how those documents feed into the certification process and what makes them audit-ready.
Health and Wellness Innovators
Understand what MDR-compliant development actually looks like: versioning, change control, testing protocols, and what your team will be asked to produce.
Expert Quote
