China · EU MDR
A free online session for China-based manufacturers (Class IIb/III) seeking CE-mark under EU MDR. Hosted by Eclevar MedTech with LINKS CRO, on Tencent Meeting, in English with live Mandarin translation.
A practical, one-hour session on the regulatory routes and clinical evidence a device needs for EU MDR certification, built from real submissions and deficiency rounds.
A focused, online session for China-based manufacturers, followed by live Q&A with the team.
Built for China-based manufacturers planning an MDR certification. Attend live for the Q&A, or register to receive the recording.
The people on the call have sat on both sides of the submission: building devices and reviewing them.
Consultant cardiothoracic surgeon of 25 years and former Team Leader and Senior Clinical Reviewer for cardiovascular devices at TÜV SÜD, where he reviewed over 400 MDR dossiers. Now COO and CMO, Cardiovascular at Eclevar MedTech.
Eclevar MedTech
Senior Clinical Reviewer and Subject Matter Expert in cardiovascular devices at TÜV SÜD. Physician trained at RWTH Aachen and the Medical University of South Carolina, with a background in cardiology and emergency medicine; focused on device software, clinical evidence, risk management and PMCF.
TÜV SÜDRegulatory affairs, PMCF clinical investigations, biometry and data management, delivered by clinicians and former Notified Body reviewers.
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.
The webinar runs on Tencent Meeting (VooV). Registration is open, the button below takes you straight to it. Free to attend, and a recording is sent to every registrant.
Free · in English with live Mandarin translation · a recording is sent to every registrant.
Register on Tencent Meeting →Yes. The August 10 webinar is free to attend.
It runs on Tencent Meeting (VooV), familiar to attendees in China and with real-time translation. The session is in English with live Mandarin translation. Joining details are sent to registrants by email. Registrants will be prompted to create a free account. Follow the instructions and log in with that account, and you will land on the registration page.
China-based medical device manufacturers looking to bring a device into, or keep it on, the EU market under MDR 2017/745. Although it is aimed first at China-based manufacturers navigating the MDR, the topics and the discussion will benefit any manufacturer applying for CE mark under MDR. It is an interactive session with a senior clinical reviewer and subject matter expert from one of the largest Notified Bodies in Europe, and the COO of Eclevar, a boutique CRO, who was previously a Team Leader and SME at that same Notified Body.
Attending live is the only way to take part in the Q&A, but it is not required. Register and we will send you the recording afterwards.
Yes. Registrants receive a recording after the webinar, whether or not they attended live.
18:30 Beijing time on 10 August 2026 (12:30 CET), running about one hour including live Q&A.
Join Dr Mark Da Costa and Margarete Fassbender on 10 August for a clear, practical view of the regulatory routes and clinical evidence EU MDR certification requires. Free, online, no obligation.
Register for the webinar