China
Clinical evidence and CERs a reviewer will accept.
A free online webinar for China-based medical device manufacturers under EU MDR 2017/745. This is the second session in a two-part series; part one ran on August 12, and this one goes deeper into the clinical evidence and the Clinical Evaluation Report.
The clinical evidence that carries a file.
Part one, on August 12, set out the EU MDR route to market for China-based manufacturers. This second webinar, on September 1, goes deeper into the evidence and the report a Notified Body reviewer actually reads, and closes with an open live Q&A. You do not need to have attended part one to follow it.
Classification, route to market and submission strategy
How your device is classified under MDR 2017/745, the route that follows from it, and how to sequence a submission so the evidence lands in the right order.
Clinical investigations and PMCF under ISO 14155 and EU MDR
Designing clinical investigations and post-market clinical follow-up that meet ISO 14155 and EU MDR, with the MILO Studio platform for data capture and surveys.
Clinical Evaluation Reports structured for the reviewer
How to build a Clinical Evaluation Report the way a reviewer reads it, so the argument and the evidence line up and deficiencies do not.
Open live Q&A session with the team
An open floor to put your own questions to the Eclevar clinicians and our former Notified Body reviewers, live on the webinar.
Clinicians and former reviewers, not generalists.
The people on the webinar have sat on both sides of the submission: building devices and reviewing them. More speakers to be announced.
Dr Mark Da Costa
Cardiac surgeon and former lead Notified Body reviewer at TÜV SÜD. Leads operations and cardiology strategy at Eclevar.
Eclevar MedTechMartin Chen
Guest speaker and clinical research partner, joining to share perspective on running clinical programmes with China-based manufacturers.
Links-CRODr Marie Fassbender
Clinical reviewer and subject-matter expert at TÜV SÜD, one of the largest Notified Bodies in Europe. Joins the live webinar Q&A.
TÜV SÜDA 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.
Save your place at the webinar.
Register for the free online webinar on September 1. It is the second session in our two-part series; if you missed part one on August 12, you can still follow this one, and we can point you to the earlier material.
Good to know.
Q.Is the webinar free?
Yes. The September 1 webinar is free and fully online. There is nothing to pay and nowhere to travel.
Q.Is the webinar recorded?
Yes. We record the session and send registrants a link afterwards, so you can catch up or share it with colleagues if you cannot attend live.
Q.Who is this for?
China-based medical device manufacturers looking to bring a device into, or keep it on, the EU market under MDR 2017/745, and the regulatory and clinical teams supporting them.
Q.How does this relate to the August webinar?
This is the second session in a two-part series. Part one, on August 12, covered the EU MDR route to market and where Notified Body deficiencies come from. This September 1 session goes deeper into clinical evidence, PMCF and Clinical Evaluation Reports. See the August webinar →
Q.Do I need to have attended part one first?
No. Each session stands on its own. Attending the August 12 webinar helps set the context, but this one is written so you can follow it without it, and we can share the earlier material with registrants.
Register for the free online webinar.
Join us online on September 1 for the second session in the series. You will get a realistic, reviewer's-eye view of clinical evidence and CERs, with no obligation.
Register for the webinar