Why MDR Technical Files Keep Breaking Down

Most MDR technical files don’t fail because teams lack expertise. They fail because the system holding the information together breaks under pressure. As products evolve, standards change, and submissions expand across markets, technical documentation becomes harder to maintain, review, and trust—leading to slow notified body reviews, repeated questions, and costly rework. In this Friday In-Focus session, Leon Kobinger (Managing Director and CEO of CertHub) and Nicolas Gehring (Managing Director and CTO of CertHub) break down the real operational bottlenecks that cause MDR technical files to break down—and what high-performing teams do differently to keep files audit-ready and submission-ready. You will learn: • Why MDR tech files collapse operationally (not technically) • The most common failure points: ownership gaps, version chaos, inconsistent traceability • How rework accumulates across GSPRs, CER, RMF, labeling, and PMS/PMCF • What notified bodies struggle with most during review (and why it slows everything down) • Practical ways to structure documentation systems so updates don’t break everything • How to reduce review cycles by improving consistency, linking, and change control Speakers: • Leon Kobinger — Managing Director and CEO, CertHub • Nicolas Gehring — Managing Director and CTO, CertHub Replay and chapters below. 00:00 – Welcome and what “technical files breaking down” really means 03:10 – Why teams get stuck: operational complexity, not lack of expertise 07:05 – The hidden bottleneck: documentation systems that don’t scale 11:40 – Version control and ownership gaps: where rework starts 16:30 – Traceability breakdowns: GSPRs, RMF, CER, labeling, PMS/PMCF 22:10 – Notified body review reality: why reviewers slow down and loop back 28:25 – Change management: how small updates cascade into major rework 34:40 – Building a resilient documentation structure (what good looks like) 41:15 – Practical workflow improvements: templates, linking, consistency checks 48:10 – Q&A and real-world scenarios 55:30 – Wrap-up and next steps