Lesson series


Clinical Evaluation under MDR

This beginner-level course provides a structured introduction to the key principles and regulatory expectations governing clinical evaluation in the medical device industry.

Participants are guided through the full clinical data lifecycle under the MDR, with a strong focus on how clinical evidence is generated, assessed, and maintained throughout a device’s lifetime.


Early Bird pricing available for
Format

Online
Course

Starting date

22.10.2026
- 08.12.2026

Recordings available for

6 months

Duration

14 sessions

Level

Beginner


Weekly 90-minute sessions every Tuesday and Thursday at 13:30 PM CET

Recordings will be available for up to 6 months.

Why should you join this course?

Clinical evaluation is crucial for medical device compliance under the MDR. Understanding how clinical evidence is generated, assessed, and maintained throughout a device’s lifecycle is essential for demonstrating safety, performance, and regulatory compliance. This course provides a practical introduction to clinical evaluation under the MDR, covering clinical data requirements, benefit-risk analysis, evidence generation strategies, and the development of Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs). Through real-world examples, participants will gain practical experience in literature searching, clinical data analysis, state-of-the-art assessments, and the use of PMS and vigilance data.

By the end of the programme, you will have a solid foundation in MDR clinical evaluation principles and be better prepared to support clinical, regulatory and post-market activities within your organisation.

What can you expect?

The course covers fundamental concepts such as benefit-risk analysis and the role it plays in demonstrating device safety and performance. It explores multiple strategies for clinical evaluations, including approaches based on clinical investigations, equivalent devices, and non-clinical data, enabling participants to understand when and how each method is applied. Core standards such as ISO 18969 are introduced to contextualize regulatory requirements.

Practical aspects are emphasized through sessions on vigilance data searches, post-market surveillance (PMS) data, and the identification and use of different types of clinical studies and publications. Participants learn how to perform effective literature searches, conduct state-of-the-art analyses, and critically analyze clinical data.

The course also provides detailed guidance on the preparation of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), along with insights into the notified body review process and common challenges observed during assessments. It concludes with a recap of key concepts and an overview of Post-Market Clinical Follow-up (PMCF) and other relevant legislation, ensuring participants have a comprehensive foundation to begin working in clinical affairs.

What's included?

14 sessions
led by experienced professionals & experts from
industry, notified body & academia.

Clinical Data & MDR / Lifecycle

Benefit-Risk Analysis

Strategies for Clinical Evaluations 

Literature Search and Documentation

State-of-the-Art and Available Knowledge

MDCG Guidances and ISO 18969

Vigilance Data Search, PMS Data 

Notified Body: Review process and typical issues observed 

Session Topics

Across 14 interactive 90-minute sessions, participants gain a structured and practical introduction to Regulatory Affairs for medical devices. Each webinar includes a 45–60 minute presentation, followed by live Q&A to foster exchange and clarity.

The program is designed for those planning a career in regulatory affairs as well as professionals in startups or MedTech companies who are newly responsible for regulatory activities.

Self-funded*

Early Bird
250€
Normal Price: 300€

The total course fee including VAT will be calculated for you during checkout. 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 offer this course to more members of your team. Please contact us on registration@edvance-medtech.com for more information.
The total course fee including VAT will be calculated on checkout.

Student**

Early Bird
200€
Normal Price: 250€

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 Septmember 22nd 2026 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.

Meet the Speakers

Michael D'Agosto

MODERATOR
Michael D’Agosto is Professor and Dean of Studies M.Sc. Medical Devices - Regulatory Affairs at Hochschule Furtwangen University. He is a medical doctor (MD) and medical engineer by training and worked in the medical device industry prior to his academic career. Michael is also Scientific Expert and Partner at Escentia GmbH.  Michael has been part of Edvance MedTech from the very beginning, sharing his expertise and experience. He is essential for our progression with his ability to explain complex issues in a comprehensible way and for his openness to support everyone. 

Cécile van der Heijden

MODERATOR
Cécile van der Heijden is an attorney-at-law at Axon Lawyers and strategist in European life sciences regulation, with expertise spanning MedTech, AI, data, biotech and health law. Her special interest lies with cross-legislation and FemTech. Recognised for her cross-legislation expertise, she brings coherence to complex regulatory frameworks. She is a frequent speaker at international conferences and has published on medical devices, data governance, and health law, as well as on history, combining professional practice with academic inquiry. 

Elisabeth Oltmanns

MANAGING PARTNER AT ESCENTIA
Elisabeth Oltmanns is a PhD student and her research focuses on the integration of clinical and non-clinical data (eclipse-md.com). With a background in Biomedical Engineering and an MSc in Regulatory Affairs, she combines technical expertise with regulatory insight. Alongside her academic work, she consults through Escentia, a boutique clinical affairs consultancy supporting medium-risk medical devices. Passionate about advancing medical device development, she is dedicated to transforming clinical evaluations from a regulatory requirement into a strategic advantage. 

Elisabeth Oltmanns

Clinical Affairs Specialist at Escentia GmbH
Sarina Zillikens is a Clinical Affairs Expert and Team Lead at Escentia GmbH, where she leads clinical evaluations in compliance with the MDR for a wide range of medical technology clients. She holds a Bachelor's degree in Biomedical Engineering and an international Master's degree in Medical Technology and Healthcare Business, completed across three countries. Combining technical expertise with deep regulatory knowledge, she has a particular interest in software and AI-based medical devices, where she leverages innovative approaches to strengthen clinical evaluation processes.

Yu Jin

MDR CLINICAL & REGULATORY AFFAIRS EXPERT | FREELANCE CLINICAL REVIEWER AT NOTIFIED BODY
Yu Jin is an MDR clinical and regulatory specialist, an MD specialised in cardiology and a PhD in cardiovascular epidemiology. With over 15 years of experience across clinical practice, research, the medical device industry, and regulatory sectors, Dr. Jin has developed a comprehensive understanding of both the clinical and scientific aspects of medical device development and evaluation.
Currently working as a freelance clinical reviewer, she performs clinical assessments at notified bodies mainly for high-risk medical devices. Her career has included previous leadership role at a Belgian notified body, overseeing clinical evaluation and investigation assessment for a wide range of devices. She is also an author of over 50 peer-reviewed scientific publications.

Adam Kleinman

ASSOCIATE DIRECTOR, MEDICAL & SCIENTIFIC WRITING AT PHILIPS | MEDICAL DEVICE REGULATION EXPERT 
Adam Kleinman is the Associate Director of Medical & Scientific Writing at Philips within the Hospital Patient Monitors business. Adam has been leading the team for 3 years and is responsible for clinical evaluations, post-market clinical follow-up, clinical investigation protocols and reports, and scientific publications. Adam has expertise handling clinical evaluations and notified body deficiency reports for devices ranging from class I to III under EU MDR during his time as a consultant at RQM+ and as a senior writer and team lead at Philips.

And more...

Our students say 

Excellent speakers, interesting discussions, fun and great atmosphere.
andrea
Your initiative is inspiring, with a great delivery and perfect timing. The team is welcoming and shows a very serious intent to find and propose ways of sailing through the realities imposed by
the MDR and its implementation...
Bruno Oliviera, cmo
It is a very interesting and informative course, excellent trainers/speakers.
peter

Offer for Teams 

Send more people from your team and get up to 40 % discount!

25% of team (min. 2) —> 10% discount 
50% of team (min. 3) —> 20% discount 
75% of team (min. 4) —> 30% discount 
Full team (min 5) —> 40% discount

Self-funded*

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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

???

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**

???

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.

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.

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