We are thankful for the opportunity to engage with a large number of attendees at the RAPS Convergence — especially our clients who stopped by — and we would like to reflect and look ahead.
This year’s Convergence brought together over 1,500 regulatory affairs professionals in Pittsburgh, PA, to share strategies for navigating the increasingly complex global regulatory landscape.
Changing Regulatory Landscape
Change has always been part of the regulatory landscape, and this year, the ongoing changes at the FDA and potential revisions to the EU MDR/ IVDR led to interesting discussions. While there are initiatives to revise the EU MDR and IVDR, this is unlikely to happen fast just considering the legal process in the EU. However, the Commission was not attending this year working on the proposal and not being able to disclose details – yet. At this time, the current regulations and deadlines still apply in the EU. However, there is pressure on the EU to change the regulations in the future.
Artificial Intelligence
The navigation of AI opportunities and challenges was the central topic during the conference as it is a topic currently with all conferences. And regulators in the US and the EU are focusing on AI.
The FDA published a draft guidance in January 2025 that provides comprehensive recommendations on content for marketing submissions and on managing the device throughout its entire Total Product Life Cycle (FDA AI Draft Guidance). In August 2025, the FDA published a final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled software functions (FDA PCCP Guidance).
In addition to publishing guidance documents, the FDA began using AI during reviews.
The EU took a different approach to AI regulation with the AI Act (EU AI Act). This new regulation is horizontal law and therefore applies to medical devices, IVDs, and all other products that include AI. Existing requirements for technical documentation, involvement of a notified body, and an authorized representative will be extended. Stay tuned for further developments and guidelines.
Several sessions focused on the use of AI within a manufacturer’s processes to support clinical studies or regulatory processes. The years ahead will undoubtedly bring substantial changes to the industry and the regulatory profession. MDSS GmbH offers the Authorised Representative service for the AI act. One stop for all your representation.
EU MDR and IVDR Updates
Based on conversations during the conference, a timeline for the EUDAMED implementation, at least for the EUDAMED modules necessary for a Minimally Viable Product, should be finalized soon. Publication of a notice in the EU Official Journal might occur in November 2025, requiring manufacturers to comply with EUDAMED requirements by May 2026. MDSS Consulting GmbH offers a comprehensive service for EUDAMED registration.
Market Access and Patient Focus
A central focus of many discussions was the emphasis on ensuring that safe and effective products reach patients quickly (“Right and fast can coexist peacefully”) and on tackling reimbursement and ethical challenges, including building trust in science.
Sessions addressed programs and strategies to support the development and approval of products for unmet needs. Contact MDSS GmbH for the new EU process for orphan devices – a new program involving the Expert panel for allowing devices on the market with limited clinical data.
The event was a great success for MDSS, providing valuable insights and perspectives that will help us further strengthen our expertise and continue delivering exceptional service to our clients.
