MedDev Day - Programma

1. Navigating Medical Device Regulations in Japan
– Authority and Stakeholder
– Risk Classification and Registration Route
– Latest regulatory updates
– Pre-submission dialogue with authority
– Breakthrough device designation

2. Navigating Medical Device Regulations in China
– Authority and Stakeholder
– Risk Classification and Registration Route
– Latest regulatory updates
– Pre-submission dialogue with authority
– Breakthrough device designation

3. With your MDR Technical File, what needs to be done in place for the submission in China and in Japan
– Additional steps to be taken
– Specific requirements, such as labelling, pre-clinical testing, clinical data, etc.

The MEA Region is characterized by a diverse, dynamic and heterogenic regulatory environment, where the CE Mark is recognized at various degrees among the different countries. With the changes introduced by the EU MDR Regulation, along with the different amendments and extended transitional period, the MEA region had to address these changes by raising awareness around the developments happening in Europe and aligning with the proposed documentation by the EU Commission, in order to ensure minimal impact on the supply of medical devices.

How did the different stakeholders from National Regulatory Authorities, Manufacturers, Distributors and Trade Association, perceive these changes and worked together to contain the situation and mitigate the risk?

From Regulators’ circulars to industry impact assessment, all the way to capacity building, this presentation will take you through the full cycle of how the MEA Region addressed the changes introduced by the EU MDR.

Starting January 1, 2026, the registration of medical devices in Russia and the Eurasian Economic Union (EAEU) will be governed exclusively by the unified EAEU regulations. These rules aim to harmonize regulatory procedures across all member states (Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan), replacing national systems. This presentation provides an overview of the new registration framework, including requirements for technical documentation, clinical data, conformity assessment process, and the responsibilities of foreign manufacturers.

The session will also focus on the transition period, outlining key deadlines, re-registration requirements for nationally approved devices, and strategic considerations for maintaining market access. Special attention will be given to the recognition of international certifications (e.g., CE mark) and estimated timelines and costs under the EAEU system.

Drawing on practical experience, the presentation will offer actionable recommendations and insights for foreign manufacturers navigating the evolving regulatory landscape and preparing for full compliance by the 2026 deadline.

Everyone talks about AI. But where is it valuable – and where is it just a fancy buzzword?

This interactive workshop helps professionals in Regulatory Affairs and Quality Management (RA/QM) critically assess the real value of AI in their daily work. Learn how to distinguish marketing fluff from meaningful innovation.

During this workshop, you will:

• Understand where AI delivers real value in RA/QM – and where it doesn’t.
• Identify typical strengths and weaknesses of AI systems compared to human expertise.
• Get to know key regulatory and safety requirements for using AI in MedTech environments (e.g., GDPR, ISO, MDR).
• Learn validation strategies like gold standard testing, cross-validation, and Turing tests to verify AI results.
• Explore real-world use cases in vigilance, complaint handling, and surveillance – with insights into what works and what to avoid.
• Work through exercises to match AI strengths with specific RA processes – and understand when humans are irreplaceable.

Living in the second (or third?) transition of the MDR us notified bodies face challenges just like all other actors of the medical device field.

Fulfilling the requirements, implementing guidance documents requires a lot of effort and flexibility. In addition, this year seems to be unique as the real-life workability of the MDR system has gained special attention. Rather than identifying pitfalls and bottlenecks we try to improve our adaptation strategies.

The latest changes and their effects from a notified body viewpoint will be presented.

The presentation will cover the following topics:

• Recent developments.
• Ongoing initiatives and priorities, targeted evaluation.
• Future of the regulatory system in Europe.

Abstract available soon

The presentation introduces Regulatory Strategy from an industry perspective focusing on ensuring compliance with evolving regulations while optimizing product development and approvals.

It highlights MDR requirements for regulatory strategies and outlines key elements of an effective regulatory approach including understanding laws and regulations, implementation mechanisms and engagement with stakeholders supported by good practice examples.

Three case studies provide real-world examples on Clinical Claims & Data, Navigating Regulatory System Gaps and Conformity Assessments alignments with ongoing testing while engaging with the notified body.

Finally the Briefing Book is presented as a Core Engagement Tool with practical dos and don’ts for successful structured dialogues with notified bodies and scientific advice with EMA.

This session will be a case study on the transferability of clinical data obtained outside of Europe to confirm the safety and performance of medical devices under Regulation 2017/745 (MDR), focusing on pre-market clinical investigations.

While the (MDR) does not explicitly require that a clinical investigation be conducted within the European Union, the Notified Body might challenge the full applicability to the European population.

We will focus on the methodology for justifying the transferability and will provide examples of the limitations of these factors.

The workshop will feature two impulse statements to frame key topics, followed by a collaborative group session focused on developing core elements of a briefing book and clinical strategy.

Participants will work in teams to co-create strategic proposals, with group outcomes presented in a plenary format.

The session will conclude with a synthesis of key recommendations.

Key Learning objectives:

• Understand how regulatory strategy integrates across clinical and corporate planning.
• Learn tools for effective communication with regulatory authorities.
• Explore pathways for incorporating global data into EU filings.
• Practice developing elements of regulatory briefing documentation.