In partnership with China · EU MDR
Wed, 12 August 2026 · 18:30 Beijing (12:30 CET) · Online · Free

Challenges in Regulatory Routes for MDR Certification.

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.

Ex-Notified Body reviewers Ex-TÜV SÜD Platinum Award · EUCROF 2026
01
Wed, 12 August · 18:30 Beijing
Challenges in Regulatory Routes for MDR Certification
The regulatory routes and clinical evidence a device needs for EU MDR certification: Article 61, the CEAR and the deficiencies reviewers see most.
Free · Tencent Meeting
What we'll cover

One hour, online, straight to the point.

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.

Agenda · Online

What we'll cover

Wednesday, 12 August 2026 · 18:30 Beijing
Free · Tencent Meeting

A focused, online session for China-based manufacturers, followed by live Q&A with the team.

  • Defining the regulatory route for your clinical evaluation under EU MDR
  • Article 61 exemptions: equivalence, legacy devices and the level of evidence needed
  • Clinical trial needs and what a Notified Body reviewer expects to see
  • CEAR format, common deficiencies and case studies, followed by live Q&A
Register for the webinar
Who it's for

Class IIb / III manufacturers

Legacy (Dec 2027 / Dec 2028) and new devices
Free · Online

Built for China-based manufacturers planning an MDR certification. Attend live for the Q&A, or register to receive the recording.

  • Regulatory, clinical and quality teams preparing an EU submission
  • Manufacturers weighing the cost and timeline of an MDR programme
  • Anyone who has had, or expects, Notified Body deficiencies
  • English on Tencent Meeting, with live Mandarin translation
Register for the webinar
Speakers

Clinicians and former reviewers, not generalists.

The people on the call have sat on both sides of the submission: building devices and reviewing them.

Prof Mark Da Costa

Prof Mark Da Costa

COO & CMO, Cardiovascular · Eclevar

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
Dr Margarete Fassbender

Dr Margarete Fassbender

Senior Clinical Reviewer · TÜV SÜD

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 SÜD
Why Eclevar

A 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.

2021
Founded
50+
EU MDR device programmes
4
Global offices
7
Countries with in-house CRAs
🏅
European champion

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.

Platinum Award xShare × EUCROF Amsterdam 2026 EU Co-Funded
Register

Save your place at the webinar.

The webinar runs on Tencent Meeting (VooV). Registration opens shortly, and the link will appear right here. Free to attend, and a recording is sent to every registrant.

Registration link (Tencent Meeting) coming soon

Join us on Tencent Meeting

Free · in English with live Mandarin translation · a recording is sent to every registrant.

Register on Tencent Meeting →
Questions

Good to know.

Q.Is the webinar free?

Yes. The August 12 webinar is free to attend.

Q.What platform is it on?

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.

Q.Who is it for?

China-based medical device manufacturers looking to bring a device into, or keep it on, the EU market under MDR 2017/745.

Q.Do I need to attend live?

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.

Q.Will there be a recording?

Yes. Registrants receive a recording after the webinar, whether or not they attended live.

Q.What time does it start?

18:30 Beijing time on 12 August 2026 (12:30 CET), running about one hour including live Q&A.

Let's talk

Register for the free EU MDR webinar.

Join Prof Mark Da Costa and Dr Margarete Fassbender on 12 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
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