EU MDR Mastery
From Classification to CE Marking
Build a complete, audit-ready Technical Documentation file for a real device — taught by a practitioner who has prepared technical files, sat through Notified Body audits, and secured CE marking. Recorded lessons at your pace, three live sessions where it counts.
TRACK
A certificate, and a submission-ready file.
Every lesson and live session feeds one cumulative deliverable — your own capstone Technical Documentation file, built on a real or realistic device, the way it will actually be reviewed. A certificate of completion is issued once it's signed off.
Complete Tech File
GSPR matrix, risk management file, clinical evaluation report, PMS/PMCF plans, and labelling — compiled and cross-referenced, not theoretical.
Registration, done right
SRN actor registration and UDI/device registration walked through live, including the naming mismatches that trip up first submissions.
Mock audit experience
Defend your own file under live, audit-style questioning before you ever have to do it for real.
Certificate of completion
Issued once your capstone Tech File and live session checkpoints are signed off — proof of work, not just attendance.
Self-paced where it can be. Live where it must be.
14 recorded lessons you watch on your own schedule, paired with 3 live 2-hour sessions reserved for correction, peer review, and audit defense — plus guided self-study and assignment time to actually build your capstone file.
Total: ~12 hrs recorded + 6 hrs live + ~12 hrs self-study & assignments = approx. 30 hours, delivered across a 10–12 week window.
14 lessons, organised the way a Tech File is built
Foundations & Strategy
- MDR vs MDD landscape
- Device classification (Annex VIII)
- Conformity assessment routes
- QMS as the Tech File backbone
Core Documentation
- GSPR compliance matrix
- Risk management file
- Annex II/III structure
- Clinical evaluation (CEP/CER)
- PMS & PMCF planning
Labelling & Registration
- Labelling & IFU
- UDI assignment
- Eudamed registration (live walkthrough)
- Compiling the final file
Sustaining Compliance
- Post-CE lifecycle management
- Significant change assessment
- Anatomy of a real deficiency letter
Taught by someone who has sat on the other side of the table
Your Instructor
An EU MDR practitioner who has personally prepared multiple Technical Documentation files, faced Notified Body audits directly, and carried devices through to CE marking. This course is built from that real submission and audit experience — not a reading of the regulation text.
Limited to 20 seats this cohort
Offer price applies to this cohort only. Enrollment closes after 20 registrations or on 4 July 2026, whichever comes first.
Frequently asked questions
Do I need a real device to take this course?
No. You will work with a mock device assigned or selected at the start of the course, used consistently across every module so your capstone Tech File stays realistic and complete.
What happens if I miss a live session?
Live sessions are where homework gets reviewed and corrected. Onboarding call details, scheduling, and any make-up arrangements will be communicated directly during onboarding on 4 July 2026.
Is this a certificate course?
Yes. You receive a certificate of completion once your capstone Tech File and all three live session checkpoints are signed off — alongside the file itself, which is the real, working credential you walk away with.
Where can I see the full syllabus?
Download the complete brochure for the full module-by-module breakdown, session timings, and assessment criteria.
Seats are capped at 20 for a reason.
This course is built around live correction and live audit defense — that only works in a small cohort. Once 20 seats are filled, or 4 July arrives, registration closes.
Note: This page presents an indicative overview of the course structure, content, and sequencing. The actual course delivered — including lesson order, exact session timings, specific topics covered, and assessment methods — may vary from this outline as the curriculum is refined and updated. It is intended to give you a clear sense of the course's depth, structure, and learning approach, and should not be treated as a final, binding syllabus.