Clinical Masterclass Option 2

Covering the full medical device lifecycle, the program features expert-led agendas developed by notified bodies and industry leaders, dedicated tracks for high- and low-risk devices, and real-world case studies designed to accelerate careers, strengthen businesses, and improve lives.

Choose Your Track

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

Real-World Case Studies

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

Led by Renowned MedTech Experts

Conference Chairs and international faculty share practical insights and experience.

Richard Holborow

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

Tom Melvin

Biomedical Alliance Europe, Edvance MedTech Scientific Board

Yu Jin

MDR Clinical Expert

Adam Kleinman

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

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

Every topic is delivered as a structured 75-minute session beginning with a brief 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.

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
Case study:

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
Case study:

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
Case study: Addressing state-of-the-art gaps without over claiming

Device specific data vs background clinical evidence
Managing limited published data e.g.innovative implantable devices
Integrating pre market and early clinical investigation data
Case study: Managing sparse published data in first MDR submissions

Understanding Article 61(10) and its limitations
Defining sufficient non-clinical and performance data
Common NB challenges and reasons for rejection
Case study: Justifying the absence of clinical data for a legacy device

Defining “sufficient clinical data” in practice
Designing investigations to demonstrate clinical benefit, safety and performance
Endpoint selection and alignment to claims
Case study: Clinical investigation design that was accepted by a NB for an implantable device

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

Why demonstrating equivalence is challenging
Requirements for access to technical documentation
Interaction between Article 61(4) and clinical investigations
Case study: Equivalence pathway for a WET implantable device

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
Case study: Justifying limited PMCF activities under the MDR

Continuous clinical evidence generation
Registries, PMCF studies and long-term follow-up
Integrating PMCF planning with risk management
Case study: Registry-based PMCF reviewed by a Notified Body

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

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 Expert

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.

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.

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Clinical Affairs Conference

Join Industry Experts in

Master the Medical Device Lifecycle from a Clinical Perspective

Choose Your Track

Real-World Case Studies

Led by Renowned MedTech Experts

Meet the Renowned MedTech Experts Chairing This Event

Richard Holborow

Tom Melvin

Yu Jin

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

Session 1A: Low Risk Devices

Session 1B: High Risk & Implantable Devices

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

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

Session 2A: Low Risk Devices

Session 2B: High Risk & Implantable Devices

13:15 - 14:15 | Lunch

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

14:45 - 16:00 | Session 3: Clinical Literature & State of the Art Evaluation

Session 3A: Literature Searches & State of the Art Challenges for Low Risk Devices

Session 3B: Clinical Literature & Device Specific Data for High Risk Devices

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

16:30 - 17:45 | Session 4: Clinical Evidence Expectations & Strategies

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

Session 4B: Clinical Investigations for High Risk Devices

Day 2 | Wednesday 10 February 2026

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

Session 5A: Low Risk Devices

Session 5B: Class III & Implantable Devices

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

10:15 - 10:45 | Keynote: Clinical Data Appraisal: transfer number into evidence by Yu Jin

10:45 - 12:00 | Session 6: Post-Market Clinical Follow-Up (PMCF) & Expectations

Session 6A: Low Risk Devices

Session 6B: High Risk & Implantable Devices

12:00 - 13:00 | Lunch

13:00 - 14:45 | Session 7: From PMS to Clinical Evidence: Closing the Loop

Session 7A: PMS Data Feeding Back into the Clinical Evaluation

Session 7B: Lifecycle Management of Clinical Evidence for Implantable

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

14:45 - 16:30 | Closing Plenary

Keynote

Panel

Conference Closing

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