Educational Webinar Series

Clinical Evaluations for Medium-Risk Medical Devices (EU MDR)

Join a community of regulatory, clinical, and quality professionals in a focused 10-part webinar series dedicated to mastering the clinical evaluation requirements for medium-risk (Class IIa/IIb) medical devices under the EU Medical Device Regulation (MDR).

This series is designed around what professionals need to know but often find overlooked in conventional training. Each session combines scientific integrity, regulatory insight, and practical application—brought to life by leading experts in the field.

Sessions will take place weekly on Thursdays at 1:00 PM, beginning January 15, 2026, and continuing for a total of 10 weeks.

We intend to make recordings of each session available to participants. However, please note that in the event of technical difficulties, recordings may not be guaranteed, and Edvance MedTech will not be held liable for any loss of access to such materials.


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Program Overview

Across 10 interactive 90-minute sessions, participants gain both regulatory perspective and hands-on tools to develop compliant, evidence-based Clinical Evaluation Reports (CERs).
Each webinar includes a 45–60-minute presentation, followed by live Q&A to foster exchange and clarity.

Introduction & Context
Tom Melvin

Associate Professor of Medical Device Regulatory Science, University of Galway;
Chair of the Regulatory Affairs Committee, Biomedical Alliance in Europe, Ireland;
Scientific Board Member, Edvance MedTech
Understand MDR requirements and expectations for medium-risk devices.

MDR Article 61(10): Non-Clinical Data Only
Ivan Stoyanov

Demonstrate safety and performance using non-clinical evidence.

Quantification of Clinical Benefits and Outcomes

Measure benefits, define endpoints, and perform benefit–risk assessment.

Surrogate Parameters
Michael D’Agosto

Professor, Hochschule Furtwangen University;
Scientific Board Member, Edvance MedTech; Partner, Escentia
Use surrogate endpoints responsibly and correlate them to clinical outcomes.

Sufficient Clinical Evidence
Amie Smirthwhite

Independent Consultant, UK
Determine when evidence is adequate and integrate PMCF strategies.

Use MDR and MEDDEV terminology accurately in CERs and submissions.

ISO 18969
Danielle Giroud

CEO, MD-Clinicals, Switzerland
Implement the concepts of the new global clinical evaluation standard and align with MDR.

Well-Established Technology (WET)
Richard Holborow

Use MDR and MEDDEV terminology accurately in CERs and submissions.

Update from the EU Commission

Review the latest MDCG guidance and regulatory trends.

Panel – Closing Session Moderator
Tom Melvin

Associate Professor of Medical Device Regulatory Science, University of Galway;
Chair of the Regulatory Affairs Committee, Biomedical Alliance in Europe, Ireland;
Scientific Board Member, Edvance MedTech
Engage with regulators, Notified Bodies, and experts on lessons learned, open questions, and future directions.

Why you should join this course

This is the first clinical evaluation training focusing specifically on medium risk devices under MDR: In an area, where most training is designed around high risk devices with a clear clinical benefit, other devices have been neglected. But especially for these devices, the requirements for clinical evidence have been hightened since the introduction of the MDR.

This course will not tell you how to write a CEP and a CER or how to perform a literature review. This course focuses on concepts, strategies and frequently discussed issues around these clinical evaluations – presented by top experts and well known spearkers in this field.

And even better: all proceeds from this series will support ECliPSE, which is a research project developed to better understand what we can learn from clinical and non-clinical data for the evaluation of medical devices.

Our speakers support both your training and the ECliPSE project by donating their time to this initiative – which means you can enjoy this series for a fraction of what you’d have to invest for a commercial event.

You will learn to

  • Interpret and apply MDR Annex XIV, Article 61, and related MDCG guidance.
  • Build a defensible CER integrating clinical, non-clinical, and literature data.
  • Quantify and document clinical benefit and benefit-risk balance.
  • Implement the concepts of ISO 18969 within clinical evaluation and QMS processes.
  • And so much more…

Specifically designed around medium-risk devices, all while staying informed on the latest EU and research developments shaping MDR compliance and supporting the ECliPSE initiative in their research on clinical vs. non-clinical data for the evaluation of medical devices.

Course Fee

All course fees are applied exclusively to program delivery and to educational research activities under the ECliPSE initiative.
Edvance MedTech operates on a non-profit basis, ensuring that participation costs reflect fair access and support for evidence-based education.

Corporate

Early Bird

500€

Normal Price: 750€

Special team pricing is available if you would like to make this course available to more members of your team. Please contact us on registration@edvance-medtech.com for more information.

Self-funded

Early Bird

250€

Normal Price: 300€

Please refer to the table at the end of this page for the total course fee including VAT for your country of residence for self-funded or student / young professional registrations.

Students / Young Professionals

Early Bird

150€

Normal Price: 175€

Verified by using Student Email or providing link to personal LinkedIn (minimum 30 connections). If no verification is provided, our registration team will contact you for alternative verification methods.

Please refer to the table at the end of this page for the total course fee including VAT for your country of residence for self-funded or student / young professional registrations.

All prices are listed excluding VAT. The applicable VAT will be added to the invoice based on your billing country in accordance with EU tax regulations.

Please note: the early bird rate will be available until December 15th, 2025 and applies only if payment is received by December 31st. Invoices will be issued by December 16th.
If payment is not received within that period, the standard course fee will automatically apply, and a corrected invoice will be issued if necessary.

Registration


Student / Young Professional / Self-funded pricing by country

Feel free to contact out team on registration@edvance-medtech.com if your country in not included and you wish to know the price including VAT before registration.

Click here to view the VAT table.

CountryVAT Rate (%)Student / Young Professional Early BirdStudent / Young Professional Standard RateSelf-funded Early BirdSelf-funded Standard rate
Net Rate                                          150,00 €                                              175,00 €
250,00 €
                                      300,00 €
Austria20%                                          180,00 €                                              210,00 €
300,00 €
                                      360,00 €
Belgium21%                                          181,50 €                                              211,75 €
302,50 €
                                      363,00 €
Bulgaria20%                                          180,00 €                                              210,00 €
300,00 €
                                      360,00 €
Croatia25%                                          187,50 €                                              218,75 €
312,50 €
                                      375,00 €
Cyprus19%                                          178,50 €                                              208,25 €
297,50 €
                                      357,00 €
Czechia21%                                          181,50 €                                              211,75 €
302,50 €
                                      363,00 €
Denmark25%                                          187,50 €                                              218,75 €
312,50 €
                                      375,00 €
Estonia22%                                          183,00 €                                              213,50 €
305,00 €
                                      366,00 €
Finland24%                                          186,00 €                                              217,00 €
310,00 €
                                      372,00 €
France20%                                          180,00 €                                              210,00 €
300,00 €
                                      360,00 €
Germany19%                                          178,50 €                                              208,25 €
297,50 €
                                      357,00 €
Greece24%                                          186,00 €                                              217,00 €
310,00 €
                                      372,00 €
Hungary27%190,50 €                                              222,25 €
317,50 €
                                      381,00 €
Iceland24%                                          186,00 €                                              217,00 €
310,00 €
                                      372,00 €
Ireland23%                                          184,50 €                                              215,25 €
307,50 €
                                      369,00 €
Italy22%                                          183,00 €                                              213,50 €
305,00 €
                                      366,00 €
Latvia21%                                          181,50 €                                              211,75 €
302,50 €
                                      363,00 €
Lithuania21%                                          181,50 €                                              211,75 €
302,50 €
                                      363,00 €
Luxembourg17%                                          175,50 €                                              204,75 €
292,50 €
                                      351,00 €
Malta18%                                          177,00 €                                              206,50 €
295,00 €
                                      354,00 €
Netherlands21%                                          181,50 €                                              211,75 €
302,50 €
                                      363,00 €
Norway25%                                          187,50 €                                              218,75 €
312,50 €
                                      375,00 €
Poland23%                                          184,50 €                                              215,25 €
307,50 €
                                      369,00 €
Portugal23%                                          184,50 €                                              215,25 €
307,50 €
                                      369,00 €
Romania19%                                          178,50 €                                              208,25 €
297,50 €
                                      357,00 €
Slovakia20%                                          180,00 €                                              210,00 €
300,00 €
                                      360,00 €
Slovenia22%                                          183,00 €                                              213,50 €
305,00 €
                                      366,00 €
Spain21%                                          181,50 €                                              211,75 €
302,50 €
                                      363,00 €
Sweden25%                                          187,50 €                                              218,75 €
312,50 €
                                      375,00 €
Switzerland8,1%                                          162,15 €                                              189,18 €
270,25 €
                                      324,30 €
United Kingdom20%                                          180,00 €                                              210,00 €
300,00 €
                                      360,00 €