Day Five – 20 June 2025Friday, 20 June 2025

• Current regulatory landscape and expectations for post market surveillance and vigilance in Europe

• Have there been any notable changes?

• Are there any areas under review to watch out for?

• Which sections of PMS guidance consistently trip people up?

• Solutions to overcome

• Market overview

• History of MD Regulation

• Key regulatory pathways for market access

• How to make product launch quicker with fast track pathways

• Post Market Requirements

• Market overview
• Key pathways
  • How to access the region
• How to make product launch quicker
  • Fast track and key pathways
• Example case study of submission

• Which standards from TC 42 ( General AI Standards) are applicable to AI-enabled devices?
  • Details from the SNAIG reports
• Status of medical standards for AI/ML
  • Testing of AI/ML IEC 63450
  • Clinical Evaluation of AI/Ml Systems (IEC 63521)
• Status update of PAS on data management and quality assessments for medical devices

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

This training provides a practical, end-to-end guide to documenting AI/ML-powered medical devices in alignment with global regulatory expectations. Designed for cross-functional teams working at the intersection of machine learning and medical device development, the session walks through each stage of the ML product pipeline — from data sourcing and preprocessing, through model development and feature engineering, to verification, validation, and post-market monitoring.

• Understanding Real-World Evidence

• Integration of RWE in Post-Market Surveillance

• Regulatory Landscape

• Case studies

• Challenges and Opportunities

• Future directions

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• The software modules and their clinical validation
• Use of data from clinical trials
• The foreseen Post Market Clinical Follow up activities
• Integrating the quality management system in life cycle management

• Role of PMS in the Benefit-Risk Framework

• Regulatory Expectations for PMS Data Collection

• Risk Identification and Management via PMS

• Impact of Post-Market Data on Benefit-Risk Decisions

• Cross-Functional Collaboration for Effective Benefit-Risk and PMS

Following on from yesterday’s morning session, our experts take the time to answer your most asked questions, comments and concerns, as well as answer any leftover burning questions!

• What are PCCPs and are they only of use in the US market?

• What are the current requirements of PCCP for AI/ML-enabled devices?

• Are they only for AI-enabled devices?

  • How can manufacturers utilise PCCPs?

• Common pain points and tips to avoid these

• With UK PMS regulations having come into force in 2024, what are our first experiences?

• Do expectations align with Europe?

• Can manufacturers streamline PMS activities for both regions?

• Are there common pain points which need addressing?

• What are the current regulatory expectations for adverse event reporting?

  • How are notified bodies assessing this?

• Industry experiences of reporting adverse events

  • Can current processes be more standardised?

  • Streamlining stakeholder interactions

  • Can AI be used to alleviate workload?

• Current European regulatory landscape around large language models

• Where do LLMs link into other current legislations?

• What implications are there for devices and diagnostics?

• What is the current impact on patient safety?

  • LLMs in practice

• How can manufacturers deploy them effectively and safely?

• Outline of a Practical Approach to Integrating MDCG 2022-21 Requirements: Effective integration into the Quality Management System to meet regulatory demands.
• Utilization of the PSUR Structure for Streamlined Input Templates: Developing department-specific templates to ensure consistent, compliant data collection across teams.
• Breaking Down Silos Through Direct Involvement: Enhancing cross-departmental collaboration by focusing on a unified PSUR project goal, rather than on isolated task completion.
• Fostering a Collaborative Environment: Bridging perspectives across departments to promote a cohesive approach to quality management.

• How do you decide what Continuous PMCF activity is appropriate for each class of device?

• What systems and tools are key for creating?

• How do you implement?

• Set up a decision tree to help guide your decisions in the PMCF World

• Can you Create a Proactive and Maneuverable PMS/PMCF System to be globally supportive

• Latest regulatory updates regarding clinical data in the EU

• What do regulators and notified bodies expect?

• Are expectations aligned?

• Documenting desirable data: a working example

  • Examples of sufficient and insufficient data

  • How to collect, harvest and utilise data from trials and real-world

  • Common pitfalls and methods to overcome

• Where can generative-AI be used for medical devices and diagnostics?

• Which areas need to be considered with employment?

  • Liability

  • Security by design

  • Intellectual property

• Which practices are in place to ensure safety of using gen-AI?

• Market overview
• Key pathways
  • How to access the region
• How to make product launch quicker
  • Fast track and key pathways
• Example case study of submission