This conference has been designed for the people actually doing the work. This is a knowledge sharing and learning event first, networking second.

The agenda has been drafted by Richard Holborow (BSI) and refined together with manufacturers and other notified bodies around what you need to know and what is useful in practice - not around what speakers want to present.

The conference covers the whole Life Cycle from a clinical perspective and the focus is on real case reports: where people ran into problems, what worked, what didn’t, and what you should keep in mind when doing the work yourself.

The aim is simple: practical insight from people who have actually been through it.

Dedicated tracks for Lower-Risk and Higher-Risk & Implantable devices

Apply concepts through real-world examples and regulatory scenarios included in each session.

Conference Chairs and international faculty share practical insights and experience.

Richard Holborow

Global Head of Clinical Compliance at BSI Notified Body (NL) & BSI Approved Body (UK)

Tom Melvin

Biomedical Alliance Europe, Edvance MedTech Scientific Board

Yu Jin

Freelance Clinical Reviewer at Notified body

Nona Heueis

Clinical Affairs and Life Sciences Expert | Head of Clinical Affairs at Heraeus Medical

Adam Kleinman

Associate Director, Medical & Scientific Writing at Philips | Medical Device Regulation Expert

The conference programme is organised into two parallel tracks, one for low or medium risk devices and one for high-risk and implantable devices. Participants pick the track most relevant for their work at registration.

Every topic is delivered as a structured 75-minute session beginning with an introduction, followed by a Notified Body perspective and three practical case presentations. This format combines regulatory insights with real-world examples, enabling participants to gain practical knowledge tailored to the challenges of their device class.
Each session will follow the structure:

Developing an evidence-based clinical strategy for lower risk devices
Clinical input into requirements engineering
Aligning clinical considerations with verification and validation planning
Identifying evidence needs early to support future clinical evaluation

Developing a clinical strategy aligned with long-term evidence generation
Integrating Clinical Affairs into design inputs and requirements engineering
Clinical considerations for verification and validation planning
Planning early for PMCF and lifecycle clinical evidence requirements

Annex XIV, Part A: Translating MDR requirements into a proportionate CEP
Defining intended purpose, clinical claims and target populations
Common pitfalls for “standard-of-care” devices
Case study: Class IIa/IIb non-implantable device with limited or no published clinical literature

Why CEPs for Class III and implantable devices are fundamentally different
Defining benefit-risk and clinical claims
Alignment between CEP and clinical development planning
Case study: Staged clinical evidence generation for an implantable device

The EHDS Act will fundamentally change how health data is accessed, shared, and reused across Europe, creating both significant opportunities and new challenges for MedTech companies. While the EHDS Act creates new opportunities for MedTech companies to access electronic health data that was previously inaccessible, it simultaneously exposes certain company-held data that may become subject to access requests from others.

This session discusses how the secondary-use regime under the EHDS Act affects clinical evidence generation, data governance, trade secrets and the competitive position of MedTech companies. It also sets out the practical steps companies should take now to prepare for both sides of the framework: leveraging new opportunities to access health data while managing new obligations around sharing and protecting company-held data.

This session examines the critical role of clinical literature and state-of-the-art evaluation in demonstrating the safety, performance, and clinical benefit of medical devices. Through practical examples, participants will explore evidence strategies for either lower-risk or higher-risk devices, including approaches for limited published data, defining the state of the art, and meeting notified body expectations.

Please choose and expand the session that best matches your area of interest or device classification:

What “state of the art” means when devices are rarely reported or described in the literature
Strategies for defining state of the art for lower-risk devices
Clinical Benefit – Direct vs indirect evidence and real world use
Notified Body expectations and common deficiencies

Device specific data vs background clinical evidence
Managing limited published data e.g.innovative implantable devices
Integrating pre market and early clinical investigation data

Understanding Article 61(10) and its limitations
Defining sufficient non-clinical and performance data
Common NB challenges and reasons for rejection

Defining “sufficient clinical data” in practice
Designing investigations to demonstrate clinical benefit, safety and performance
Endpoint selection and alignment to claims

When equivalence is acceptable (& when it‘s not)
Technical, biological and clinical characteristics: Applying proportionate expectations
Accessing and documenting data: Ensuring sufficient access

Why demonstrating equivalence is challenging
Requirements for access to technical documentation
Interaction between Article 61(4) and clinical investigations

Clinical data appraisal is an essential step in clinical evaluation as per MDR Annex XIV Part A 1 (c). It is performed by evaluating the suitability of clinical data for establishing the safety and performance of the device. This keynote will focus on the methods to properly conduct data appraisal and generate evidence beyond the numbers. It will also discuss common pitfalls observed during notified body review related with data appraisal, especially in devices that have multiple sources of clinical data.

When PMCF studies are and are not expected
Using PMS data, complaints, vigilance and trend reporting: Is this sufficient?
Developing a proportionate PMCF strategy

Continuous clinical evidence generation
Registries, PMCF studies and long-term follow-up
Integrating PMCF planning with risk management

Updating the CER using PMS data
Common NB non-conformities related to PMS-CER (risk disconnect)
Maintaining clinical claims throughout the product lifecycle

How PMCF drives CER updates
Managing evolving benefit-risk profiles
Handling emerging safety signals and implementing corrective actions

Closing Thanks and Farewell

Case Studies

Which project have you worked on that others could learn from?

We already have plenty of ideas and examples for the agenda. But the more experiences we can bring together, the more useful the conference will be for everyone.

That’s why we’re looking for real case studies from people doing the work. Maybe a project didn’t go to plan. Maybe you had to make a difficult decision. Or perhaps you found an approach that worked particularly well. These are exactly the kinds of experiences others can learn from.

What about NDAs?

We all work under NDAs, so of course no one expects you to share confidential information or company secrets. But you may be able to adapt the experience to a different device, anonymise the details, or frame the story in another way. The important thing is the lesson, not the confidential specifics.

Keep it simple

Your presentation only needs to be 10 minutes, followed by 5 minutes of discussion. You don’t need to be an experienced speaker, and this isn’t about delivering a perfectly polished conference talk. It’s simply about sharing what you learned.

Introductions / NB perspective
We’re also looking for experienced speakers who can introduce one of the topics with a 15-minute presentation or share a notified body perspective on the topic, again in a 15-minute slot.

As a thank you

1 selected case study / speaking slots: 50% off your conference ticket

2 selected case studies / speaking slots: a free conference ticket

Please submit your case study by October 15. Our Chair Team will then select the cases we believe will work best for the programme.

Already bought your ticket? No problem. Whether you booked early for the best price or simply didn’t want to miss out because places are limited, we’ll reimburse the difference if your case study is selected. You won’t pay more than you need to.

If you have a project you could share, please get involved. The more honest, real-world experiences we can bring together, the more valuable we can make the conference for everyone.

Tom Melvin

Biomedical Alliance Europe, Edvance MedTech Scientific Board

Tom Melvin is Associate Professor of Medical Device Regulatory Science at the University of Galway. Tom is Chair of the Biomedical Alliance Regulatory Affairs Committee and a member of the European Medicines Agency Expert Panels for medical devices, the European Society of Cardiology Regulatory Affairs Committee and the National Research Ethics Committee for Medical Devices. 

Tom previously worked at Trinity College Dublin and was a senior medical officer for medical devices at the Health Products Regulatory Authority and Co-Chair of the

MDCG CIE working group.

Tom has been part of Edvance MedTech from the very beginning, contributing invaluable knowledge and insight, while also keeping the founding team grounded and focused when our ideas risked running too wild.

Richard Holborow

Global Head of Clinical Compliance at BSI NotifiedBody (NL) & BSI Approved Body (UK)

Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

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.

Nona Heueis

Clinical Affairs and Life Sciences Expert | Head of Clinical Affairs at Heraeus Medical

Nona Heueis is a microbiologist with a Phd focusing on RNA biology and antibiotic producing bacteria. Leaving academia behind and re-orienting towards industry came easy but scientific focus and love for evidence-based work stayed with her. She accompanied the (mindset) transition into MDR and navigates global strategy for medical devices in orthopedy and trauma with her growing team.

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.

Self-funded*

~~500 €~~ 400€

Corporate

~~750 €~~ 500 €

* 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.

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Frequently asked questions

Why do I have to select a track?

To create the best experience for all participants, the conference is organised into two dedicated tracks: Lower & Medium-Risk Devices and High-Risk & Implantable Devices. Due to limited room capacity, participants are asked to select one track when registering.

A mixed track will be available but is subject to limited capacity.

What if I want to attend sessions from both tracks?

We understand that some sessions in both tracks may be relevant to you. Participants registered for the mixed track can choose to attend sessions from either track A or track B. For selected sessions, a live stream of the session will also be available in a separate room, allowing participants to follow a session from the other track. Please note that participants cannot attend both sessions simultaneously and that the streaming room has limited capacity. In the event of full capacity, priority for the live session will be given to participants who registered for the track in question. Registration for the mixed track is also subject to limited capacity.

What certificates can I receive?

All participants will automatically receive a Certificate of Attendance after the conference. If you complete a short online knowledge test after the event, you can also receive a Certificate of Completion.

How do I submit a case study?

Please click on “Get involved” on our website or use the case study submission form.

Is there a specific format for case study submissions?

You do not need to prepare a presentation at the application stage. The submission form is designed to give us an understanding of your proposed case, the key insights or challenges, and the value it could bring to the audience.

Do I need to submit my presentation with my application?

No. A presentation is not required at this stage. If you feel that sharing a presentation would provide significantly more insight into your proposed contribution, you are welcome to submit it separately via clinical.conference@edvance-medtech.com. However, polished slides are not a requirement — the content and value of the case are much more important to us than the presentation format.

What is the format of each case presentation?

Each presentation will be 15 minutes in total, consisting of:

10 minutes for the presentation
5 minutes for questions and discussion

The presentation will be positioned within the context of a Notified Body perspective and an introduction to the overarching topic. Each session will feature three presentations, with the aim of providing complementary insights into the topic.

What makes a good case study?

We are particularly interested in cases that provide genuine learning and practical insights. A challenge, setback or unexpected outcome can be just as-or even more-valuable than a process that went smoothly. We encourage you to consider:

What can the audience learn from your experience?
Does the case provide an insight that others can apply to their own work?
Does it address a challenge that occurs regularly in practice?
Does it reveal a particular pattern, lesson or approach that others may not have considered?
Does it complement the other contributions in the session?

Does the case need to be a common or frequently occurring issue?

Not necessarily. Recurring challenges can be particularly valuable because of their practical relevance, but a rare or “corner case” can also be highly valuable if it provides meaningful insight into a specific issue, pattern or lesson.

Do I need to be an experienced presenter?

No. We are not looking primarily for polished presentations or extensive speaking experience. While these can be helpful, our focus is on the quality and relevance of the content. Our aim is to identify real-world insights that participants can take away and apply in their day-to-day work, rather than simply great presentations that leave the audience inspired but without a tangible learning outcome.

How will case studies be selected?

Submissions will be reviewed against several criteria, with particular attention to:

Learning value: What can the audience take away from the case?
Relevance and applicability: Can the insight be applied to participants’ day-to-day work?
Complementarity: Does the case add a new perspective to the other contributions in the session?
Quality of insight: Does the case reveal a meaningful challenge, lesson, pattern or solution?

I’ve already bought my ticket. If my case study is selected, will I get reimbursed?

If your case study is selected, you’ll receive a discount on your conference ticket as a thank you for contributing:

1 selected case study / speaking slot: 50% off your conference ticket
2 selected case studies / speaking slots: Your conference ticket is free

If you have already purchased your ticket, we will reimburse the applicable discount amount.

Please submit your case study by 15 October 2026. Our Chair Team will then select the cases that they believe will work best for the programme.

Will there be a group discount?

Yes. A small group discount will be available once the Early Bird tickets have sold out. However, Early Bird tickets will remain by far the most cost-effective option, so we recommend booking early.

What language will the presentations be held in?

All presentations will be held in English.

Purdie Pascoe

Thanks to the generous support of our sponsor, Purdie Pascoe, we’ve been able to increase the number of Early Bird tickets from 20 to 50!

That means more opportunities to join us in Berlin, connect with peers and Notified Body experts, and take part in two days of practical learning.

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Courses

We are a non-profit initiative built by professionals who have worked inside regulation, law, and medicine. Our independence and diversity ensure that education and research serve learners, not commercial agendas.

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info@edvance-medtech.com
Contact Us

Clinical Evaluation: An Educational Conference by Edvance MedTech

Master the Medical Device Lifecycle: a Clinical Affairs Conference

Choose your track

Real-World Case Studies

Led by Renowned MedTech Experts

This event has been designed by

Richard Holborow

Tom Melvin

Yu Jin

Nona Heueis

Adam Kleinman

Conference Agenda

Day 1 | Tuesday 9 February 2027

08:30 - 10:00 | Opening Session

10:00 - 10:15 | 15-minute Break

10:15 - 11:30 | Session 1: Clinical Affairs Activities during Early Device Development

1A: Low Risk Devices

1B: High Risk & Implantable Devices

11:30 - 12:00 | 30-minute Break

12:00 - 13:15 | Session 2: Clinical Evaluation Planning

2A: Low Risk Devices

2B: High Risk & Implantable Devices

13:15 - 14:15 | Lunch

14:15 - 14:45 | Keynote by Cécile van der Heijden: EHDS Act's Secondary-Use Regime

14:45 - 15:00 | 15-minute Break

15:00 - 16:15 | Session 3: Clinical Literature & State of the Art Evaluation

3A: Low Risk Devices

3B: High Risk & Implantable Devices

16:15 - 16:45 | 30-minute Break

16:45 - 18:00 | Session 4: Clinical Evidence Expectations & Strategies

4A: When Clinical Data Is ‘Not Appropriate’ – Article 61(10)

4B: Clinical Investigations for High Risk Devices

Day 2 | Wednesday 10 February 2027

08:30 - 09:45 | Session 5: Equivalence & Benchmarking

5A: Low Risk Devices

5B: High Risk & Implantable Devices

09:45 - 10:15 | 30-minute Break

10:15 - 10:45 | Keynote by Yu Jin: Clinical Data Appraisal - Beyond the Numbers

10:45 - 11:00 | 15-minute Break

11:00 - 12:15 | Session 6: Post-Market Clinical Follow-Up (PMCF) & Expectations

6A: Low Risk Devices

6B: High Risk & Implantable Devices

12:15 - 13:15 | Lunch Break

13:15 - 14:30 | Session 7: From PMS to Clinical Evidence - Closing the Loop

7A: PMS Data Feeding Back into the Clinical Evaluation

7B: Lifecycle Management of Clinical Evidence for Implantable

14:30 - 15:00 | 30-minute Break

15:00 - 16:30 | Closing Plenary

Keynote - tbd

Panel - tbd

Conference Closing

Get involved

Meet the Conference Chairs

Registration

We have a limited number of Early Bird tickets available at 400 EUR plus VAT for self funded and 500 EUR plus VAT for corporate registration.