Clinical Masterclass

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

MDR Clinical & Regulatory Affairs Expert | Freelance Clinical Reviewer & Clinician providing 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 & Clinician providing at Notified Body

Yu Jin is a clinical and regulatory affairs specialist with an MD and PhD in cardiology and 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 a consultant, her career has included leadership roles in clinical and regulatory strategy, particularly in the areas of EU MDR clinical evaluations and clinical investigations. Dr. Jin has extensive expertise in the Notified Body conformity assessment process, including Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) studies, and clinical investigations.An author of over 50 peer-reviewed scientific publications, Dr. Jin is also recognized for her deep clinical expertise in cardiovascular devices.

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 €

Corporate

750 €

Please note that an early bird rate will be offered for this course. Further details about the validity period will be shared soon.

* 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.

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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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Clinical Affairs Conference

Join Industry Experts in

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 2026

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

16:00 - 16:30 | 30-minute Break

16:30 - 17:45 | 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 2026

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 - 13:00 | Lunch Break

13:00 - 14:45 | 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

14:15 - 14:45 | 30-minute Break

14:45 - 16:30 | Closing Plenary

Keynote - tbd

Panel - tbd

Conference Closing

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Master the Medical Device Lifecycle:
a Clinical Affairs Conference

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