MedDev Day - Programma

This interactive workshop will align participants on key MDR challenges and expectations, and compare them with current EU proposals. Attendees will work in focused groups on conformity assessment, regulatory predictability, clinical evaluation, and international alignment to identify system gaps and improvement areas.

Each group will assess whether EU proposals address the identified issues and develop targeted recommendations.

The session will deliver clear outputs: top challenges, evaluation of EU solutions, and actionable proposals to strengthen the MDR framework.

Since 2022 the EU Commission is trying to address the challenging experience with the implementation of the EU Legislations EU MDR and EU IVDR.
In 2025, various measures were initiated including a proposal to simplify the requirements written in the initial legislative text without negatively impacting the safety of devices placed on the Union Market.

During this session, the recent proposal will be summarized and discussed with key stakeholders enabling the audience to understand the benefits and challenges related to this proposed revision.

The Annex VII Implementing Act aims to standardize European medical device certification by enforcing mandatory timelines and increasing clinical scrutiny, enhancing predictability for manufacturers while challenging Notified Bodies. Key changes include structured dialogues, rigorous evaluation of clinical evidence, and clearer change management processes.

The session will highlight the following:

• Context: Why the Annex VII Implementing Act?
• The Changes: What does the New Act change?
• Clinical Evaluation Impact: Stricter standards, faster deadlines.
• NB Perspective: Challenges in resource and quality.
• Best Practices: How manufacturers can adapt.

The introduction of Regulation (EU) 2017/745 has significantly raised expectations for the clinical evidence required to demonstrate conformity with the General Safety and Performance Requirements. From a Notified Body perspective, clinical evaluations must now present a structured, methodologically sound, and device specific evidence package that clearly supports safety, performance, and the claimed clinical benefits.

Manufacturers are expected to follow a rigorous approach to clinical evaluation, including a systematic literature review, critical appraisal of data, and clear traceability between clinical claims and supporting evidence. A key challenge remains determining what constitutes “sufficient clinical data.” Under MDR, sufficiency is defined not by quantity but by the relevance, quality, and robustness of data in addressing clinical risks and supporting the device’s benefit risk profile.

This presentation will outline current MDR expectations and highlight common deficiencies observed by Notified Bodies, offering practical guidance to help manufacturers prepare compliant and defensible clinical evidence packages.

Clinical evaluation is a cornerstone of conformity assessment under the EU MDR, yet its practical implementation remains complex and continuously evolving. Current expectations require robust clinical evidence, systematic state-of-the-art analysis, and continuous benefit–risk evaluation supported by post-market data.

At the same time, recent regulatory proposals signal a shift in how clinical evidence may be generated and justified. Concepts such as increased flexibility in evidence pathways, greater use of non-clinical data where appropriate, and new mechanisms for breakthrough and orphan devices may reshape the clinical evaluation landscape.

This presentation provides a concise overview of clinical evaluation requirements today, followed by a forward-looking perspective on what may change under a future MDR framework. It highlights strategic implications for manufacturers, including how to design efficient, compliant, and future-ready clinical evidence strategies.

As Co Lead of Work Package 20 within the MDCG CIEPSE Working Group, the presenter shares key insights from the EU pilot on coordinated assessment of clinical investigations and performance studies. Launched in 2025, this pilot aims to improve collaboration among Competent Authorities and streamline the assessment process for sponsors across the European Union.

Having co-authored the Standard Operating Procedure guiding authorities and sponsors through the processes under MDR Article 78 and IVDR Article 74, the presenter offers practical perspectives from one of the first successfully completed coordinated assessments. The contribution highlights how the procedure works in practice, the challenges encountered during the pilot phase, and the added value of coordination at EU level.

Early results demonstrate that coordinated assessment strengthens transparency, consistency, and efficiency within the European oversight system – providing clearer pathways and greater predictability for both authorities and sponsors.

The EU Medical Device Regulation (MDR) introduced the concept of a coordinated assessment for multinational clinical investigation applications to address long‑standing inefficiencies associated with parallel national reviews. Under the traditional model, sponsors were required to submit and manage separate applications in each Member State, resulting in divergent timelines, the potential for duplicate requests for information, and inconsistent regulatory interpretations.

This presentation provides an industry sponsor perspective on the transition from individual national assessments to the coordinated assessment framework envisaged under Article 78 MDR. It draws on direct experience with a multinational clinical investigation that underwent independent review in four EU Member States, highlighting practical challenges such as asynchronous assessments and varying documentation expectations.

Against this background, the EU coordinated assessment pilot is discussed as a meaningful step toward greater harmonization. Key elements of the coordinated approach, including single submission, joint scientific assessment, and consolidated feedback, are contrasted with prior sponsor experience. The presentation concludes with an industry‑focused reflection on anticipated benefits and potential challenges as coordinated assessments move toward broader implementation.

The European Commission’s December 2025 proposal introduces focused changes that streamline post market oversight. Among them, the reduced PSUR frequency and their integration into routine notified body surveillance support a more risk proportionate approach. In addition, extending the reporting deadline for certain serious incidents to 30 days adjusts vigilance requirements while maintaining regulatory responsiveness.

From one side, these measures reduce the documentary burden for manufacturers; from the other, they introduce a new balance for Notified Bodies: fewer formal recurrences, but a greater need for continuous and critical analysis of post market data, supported by more targeted and responsive surveillance activities. This shift toward a more “intelligent” model raises important questions: how will review methodologies evolve? Which new prioritization criteria will emerge? And to what extent will the proposed flexibility preserve the robustness of the regulatory system?

The presentation will explore these dynamics, highlighting both the opportunities and the challenges that the new framework poses for Notified Bodies as they work to maintain the delicate balance between regulatory simplification and patient safety.

This presentation reviews evolving EU MDR vigilance expectations, including recent draft guidance, proposed changes to vigilance reporting, and the updated Manufacturer Incident Report (MIR) form v7.3.1, mandatory from 1 May 2026. It outlines the implications for reportability decisions, reporting timelines, data quality, and cross-functional workflows.

The session examines whether revised reporting timelines enhance patient safety through faster signal detection or risk compromising report quality. It also considers how evolving expectations may require manufacturers to adapt processes and behaviors, potentially fostering a more proactive safety culture while increasing operational demands.

Overall, the presentation offers a balanced perspective on whether these developments represent a positive step for patient safety and regulatory effectiveness.

Post-Market Clinical Follow-up (PMCF) is a mandatory element of post-market surveillance under the EU Medical Device Regulation (MDR), requiring manufacturers to implement proactive, systematic and proportionate clinical data collection throughout the device lifecycle. This presentation provides an industry perspective on the practical implementation of MDR PMCF requirements and the regulatory considerations driving PMCF strategy selection.

The presentation will discuss differentiated PMCF approaches applied across device risk classes and product lifecycles, including high- versus low-risk devices and new product development compared with legacy devices transitioning to MDR compliance. Examples will demonstrate how PMCF strategies are tailored based on device risk, novelty, residual clinical uncertainties and the existing body of clinical evidence.

Key regulatory learnings related to proportionality, feasibility, data relevance and regulatory acceptance will be shared, with a focus on maintaining MDR compliance while applying least burdensome PMCF approaches.

The implementation of Regulation (EU) 2017/745 (EU MDR) has transformed post-market obligations for medical device manufacturers. The regulation represents a decisive shift from a predominantly pre-market approval model to a continuous, lifecycle-based evidence framework. Under EU MDR, demonstrating safety and performance at the point of CE marking is no longer sufficient; manufacturers must now proactively generate, assess, and document real-world evidence (RWE) throughout the device’s lifetime.

A central pillar of this lifecycle model is Post-Market Clinical Follow-up (PMCF). Annex XIV Part B makes clear that clinical evaluation is not a one-time exercise but an ongoing process requiring active and systematic collection of post-market clinical data. Manufacturers must define how they will confirm safety and performance in real-world use, identify previously unknown risks and ensure continued acceptability of the benefit-risk profile. PMCF is therefore not optional, it is a mandatory requirement demanding structured data collection activities. Among the various methodologies available, including clinical investigations, registries, literature reviews, and database analyses, surveys have emerged as a pragmatic, scalable, and cost-effective tool for generating targeted PMCF data across a wide range of device types and risk classes.

This presentation explores the regulatory, operational, and strategic role of surveys in achieving and maintaining compliance under EU MDR. It examines how structured survey methodologies can be planned and designed to ensure both the quality and quantity of data is met, and how they can generate robust real-world and PMCF data and ultimately allow manufacturers to meet their EU MDR obligations.

The presentation explores the role of Real-World Data and Real-World Evidence in supporting innovation, evaluation, and regulatory decision making throughout the lifecycle of medical devices. It explains how data collected outside randomized clinical trials can complement traditional clinical research by identifying evidence gaps, assessing safety and effectiveness, and supporting both pre-registration and post market activities. The talk introduces key sources of real-world data such as electronic health records, patient registries, insurance claims, ad hoc data collection, and digital health technologies, and discusses their strengths and limitations.

Several case studies demonstrate the practical application of real-world evidence in clinical and regulatory contexts, including external control arms, multinational safety analyses, screening programs, and optimization of device design and patient adherence. The presentation also links these examples to recent regulatory developments, including new MDCG initiatives and evolving EU MDR expectations that place greater emphasis on continuous clinical evaluation, PMCF, and integration of real-world evidence into clinical evaluation reports and lifecycle documentation.

It highlights how current guidance increasingly recognizes RWE as a valid scientific contribution to benefit risk assessment and regulatory submissions, supporting decision making across the total product lifecycle. Finally, it addresses key challenges such as data quality, privacy protection, methodological rigor, and regulatory requirements, emphasizing the need for expert collaboration and robust data management to ensure reliable and meaningful results.

The EUDAMED four first modules will be mandatory to use as from 28 May 2026.

If you haven’t successful uploaded your data in EUDAMED do not be fooled it takes a long time to correctly prepare for EUDAMED.

This session will highlight some of the pitfalls, experiences to date, and what is actually needed to submit your data to EUDAMED while keeping budgets as low as possible. And what happens if you miss final deadlines in November 2026.