Lesson series

Educational Webinar Series: Clinical Evaluations for Medium-Risk Medical Devices (EU MDR)

This comprehensive webinar series provides regulatory, clinical, and quality professionals with a structured pathway to master the clinical evaluation requirements for medium-risk (Class IIa/IIb) medical devices under the EU Medical Device Regulation (MDR).

All proceeds from this series will support the ECliPSE research project, an Edvance MedTech initiative dedicated to improving the scientific and regulatory understanding of clinical evidence sufficiency for medical devices.

Format

Online
Course

Starting date

January 15, 2026

Available for

6 months

Duration

10 sessions


Weekly sessions every Thursday at 1:00 PM CET

Recordings will be available for up to 6 months.

What can you expect?

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

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 heightened since the introduction of the MDR




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…

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 speakers in this field.

Self-funded*

Early Bird
250€
Normal Price: 300€

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

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.

Student**

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 the page for the total course fee including VAT for your country of residence for self-funded or student / young professional registrations.


Please note: The early bird rate will be available until January 10th, 2025 and applies only if payment is received by that date. If payment is not received within that period, the standard course fee will automatically apply, and a corrected invoice will be issued if necessary.

* Self-funded professional discounts apply exclusively to registrations and payments made by natural persons as B2C Customers. If a Customer provides a VAT number or business information beyond a business email address during registration, Edvance MedTech will classify the registration as a B2B Customer registration, making the self-funded professional discount inapplicable. In such cases, Edvance MedTech will invoice the Customer for the price difference and applicable VAT. Access to the relevant Educational Services will be withheld until full payment of this invoice is received.

**Student discounts apply exclusively to registrations and payments made by natural persons as B2C Customers who provide valid proof of current enrollment in an accredited educational institution or graduation from an accredited educational institution within the past three years. If a Customer provides a VAT number or business information beyond a business email address during registration, Edvance MedTech will classify the registration as a B2B Customer registration, making the student discount inapplicable. In such cases, Edvance MedTech will invoice the Customer for the price difference and applicable VAT. Access to the relevant Educational Services will be withheld until full payment of this invoice is received.

Self-funded*

300€

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

Corporate

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.

Student**

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 the page for the total course fee including VAT for your country of residence for self-funded or student / young professional registrations.


Please note: The early bird rate ended January 10th, 2025 and applies only if payment is received by that date. If payment was not received within that period, the standard course fee will automatically apply, and a corrected invoice will be issued if necessary.

* Self-funded professional discounts apply exclusively to registrations and payments made by natural persons as B2C Customers. If a Customer provides a VAT number or business information beyond a business email address during registration, Edvance MedTech will classify the registration as a B2B Customer registration, making the self-funded professional discount inapplicable. In such cases, Edvance MedTech will invoice the Customer for the price difference and applicable VAT. Access to the relevant Educational Services will be withheld until full payment of this invoice is received.

**Student discounts apply exclusively to registrations and payments made by natural persons as B2C Customers who provide valid proof of current enrollment in an accredited educational institution or graduation from an accredited educational institution within the past three years. If a Customer provides a VAT number or business information beyond a business email address during registration, Edvance MedTech will classify the registration as a B2B Customer registration, making the student discount inapplicable. In such cases, Edvance MedTech will invoice the Customer for the price difference and applicable VAT. Access to the relevant Educational Services will be withheld until full payment of this invoice is received.