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Hear the evidence expectations for robotic orthopaedic systems straight from a Notified Body.
A rare, free online session where a SZUTEST reviewer (Notified Body, NB 2975) and an Eclevar MedTech CMO set out, side by side, exactly what a robotic orthopaedic or surgical system must prove under EU MDR, and where submissions most often fall short.
Guidance you rarely get before you submit.
Most manufacturers only learn what a Notified Body expects once deficiencies land. This session puts that insight in front of you first.
Straight from a Notified Body
Hear evidence expectations directly from a SZUTEST reviewer (NB 2975), not second hand. This is the room manufacturers rarely get into.
Reviewer and clinician together
The Notified Body that assesses the evidence and the CMO who builds it, on the same call, answering the same questions.
Avoid the common gaps
See the recurring shortfalls in robotic system submissions, so you can close them before they turn into deficiencies.
Built for robotic systems
Software, navigation, workflow, usability and PMCF, addressed specifically for robotic orthopaedic and surgical devices, not generic implants.
The evidence a robotic system needs, straight from the reviewers.
A practical, online session built with a Notified Body, on how robotic orthopaedic and surgical systems are assessed under EU MDR 2017/745, and where manufacturers most often fall short. It starts at 15:00 CET.
Clinical evidence expectations for robotic orthopaedic systems under EU MDR
What a Notified Body actually looks for in the clinical evidence package for a robotic orthopaedic system, and how those expectations map to MDR 2017/745.
How evidence needs differ from conventional implant pathways
Where a robotic system parts ways from a conventional implant, and why the same clinical strategy will not carry across.
The role of software, navigation, workflow and usability in the evidence package
Why software, navigation, surgical workflow and usability sit at the centre of the evidence, not at the edge of it.
PMCF considerations after certification
What post-market clinical follow-up looks like once a robotic system is on the market, and how to plan it before certification, not after.
Common manufacturer gaps and practical lessons
The recurring gaps that lead to deficiencies, and practical lessons drawn from real assessments, followed by live Q&A.
The reviewer and the clinician, on the same call.
Two sides of the same submission, in one room: the Notified Body that decides whether your evidence holds, and the CMO who builds evidence to that bar.
Dr Engin Çamer
Leads clinical assessment at SZUTEST, a Notified Body (NB 2975). He brings the reviewer's own view of what a robotic orthopaedic evidence package has to demonstrate to clear EU MDR, the guidance you almost never hear before submission.
SZUTEST · NB 2975
Dr Nikhil Khadabadi
Chief Medical Officer at Eclevar MedTech. He shows how clinical evidence and PMCF programmes for robotic and surgical systems are built to meet that bar, from strategy through to a submission that stands up to review.
Eclevar MedTechA European CRO built for EU MDR clinical trials.
Regulatory affairs, PMCF clinical investigations, biometry and data management, delivered by clinicians and former Notified Body reviewers.
Platinum Award, xShare × EUCROF 2026
Top prize in the xShare × EUCROF Open Call for clinical research, awarded to Eclevar MedTech and its MILO Health platform, and presented at the EUCROF 2026 conference in Amsterdam. Co-funded by the European Union.
Get evidence expectations straight from the source.
Claim your free place at the 9 September webinar with Eclevar MedTech and SZUTEST (Notified Body, NB 2975). Register on Zoom to get your unique joining link by email — and the recording afterwards if you cannot attend live.
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Good to know.
Q.Is the webinar free?
Yes. The 9 September webinar is free to attend.
Q.Is it online?
Yes. It is a fully online webinar, so you can join from anywhere. It starts at 15:00 CET, and your joining link is sent by email when you register on Zoom.
Q.Is it co-hosted with a Notified Body?
Yes. This is a joint webinar between Eclevar MedTech and SZUTEST, a Notified Body (NB 2975), so you hear both the reviewer's view and the clinical team's view on the same call.
Q.Who is it for?
Medical device manufacturers of robotic orthopaedic and surgical systems seeking or holding EU MDR certification, along with their regulatory, clinical, software and quality teams.
Q.What will I learn about robotic systems?
What clinical evidence robotic orthopaedic systems need under EU MDR, how that differs from conventional implant pathways, the role of software, navigation, workflow and usability, PMCF after certification, and the common gaps that lead to deficiencies.
Q.Will there be a recording?
Yes. Registrants receive a recording after the webinar, whether or not they attended live.
Register for the free joint webinar, 9 September 2026.
Hear a Notified Body and a clinical team set out, side by side, what a robotic orthopaedic system needs to show under EU MDR. Free, online, no obligation. Starts 15:00 CET.
Register for the webinar