The 2025 Medical Device Single Audit Program (MDSAP) Forum was held in person in Amsterdam, the Netherlands, from 16 to 20 June 2025. The Forum was co-chaired by Australia’s Therapeutic Goods Administration (TGA) and Health Canada on behalf of the MDSAP Regulatory Authority Council (RAC). As an authorized MDSAP Auditing Organization, DQS attended the Forum to actively engage with regulators and stakeholders, contribute to discussions on program performance and enhancements, and stay at the forefront of regulatory developments shaping the future of MDSAP.
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The event welcomed approximately 115 in-person participants and 75 virtual attendees during the two public (Open Agenda) days, with a further 70 in-person participants attending the closed sessions later in the week. Attendees represented a broad range of stakeholders, including MDSAP Regulatory Authorities, Official Observers and Affiliates, EU Competent Authorities, MDSAP Auditing Organisations (AOs), EU Notified Bodies, and industry representatives.
Purpose and scope of the Forum
The annual MDSAP Forum provides a platform for stakeholders to engage on the operation and performance of the program, share experiences, and support continuous improvement initiatives. It also serves as a key opportunity for face-to-face training for Observers and MDSAP Auditing Organisations.
The 2024 and 2025 Forums were intentionally held in Europe to further support harmonization efforts and deepen understanding of MDSAP among EU Competent Authorities. Feedback from participants confirmed the ongoing value of these discussions and reinforced the importance of continued industry involvement to support the evolution of the program.
Open Agenda sessions and stakeholder engagement
The Open Agenda sessions, held on 17 and 18 June 2025, brought together all stakeholder groups. Introduced by the MDSAP RAC Chair and representatives from the European Commission, the EU Notified Body Coordination Group (NBCG-Med), and the Global Medical Technology Alliance, the sessions covered:
- Operation and performance of the MDSAP
- Recent performance data
- Strategic direction of the program
Observers, EU Member States, and Affiliates also shared perspectives on the benefits, challenges, and opportunities associated with MDSAP participation in their jurisdictions. The contributions of all presenters and participants were instrumental in identifying opportunities for further enhancements and future projects.
Performance data highlights
Performance data presented during the Open Sessions demonstrated continued growth and global uptake of the MDSAP:
- 31,426 MDSAP audits conducted (January 2018 – May 2025)
- 15 authorized Auditing Organisations
- 82 countries where MDSAP audits have taken place
- 7,357 active facilities, up from 7,060 in 2024
The MDSAP RAC also confirmed plans to publish more detailed performance data on the program website in 2026.
Progress on the MDSAP Enhancement Program
Participants received updates on priority projects under the MDSAP Enhancement Program, initially agreed by the RAC in 2023. Key focus areas include capacity, timeliness, performance monitoring, quality improvement, engagement, and transparency.
Major milestones announced at the Forum included:
- Implementation of a remote and hybrid auditing procedure following a successful pilot program
- Re-opening of applications for new Auditing Organisations from 1 July 2025, supported by prioritization criteria
- Official launch of the new independent website MDSAP.global
- Introduction of an AO financial contribution scheme to support long-term sustainability
- Completion of a non-conformity writing improvement project, including updated procedures, forms, and AO training
Closed sessions and RAC meetings
The closed sessions provided targeted training, discussion, and knowledge-sharing opportunities, including participation from EU Member States to support mutual learning and exchange of regulatory experience. Priorities for future training and topics for the December 2025 Technical Meeting were also discussed.
During the Forum, the MDSAP RAC met formally and with Observers, Affiliates, and EU Member States to reflect on outcomes and agree on next steps. The RAC committed to providing more opportunities for Observers and Affiliates to share feedback and discuss program use during future Open Agenda sessions.
If you are planning to implement or transition to MDSAP, or are looking to optimize your existing audit program, DQS supports you with experienced auditors, global regulatory expertise, and a practical approach to MDSAP compliance. Contact us to learn how we can support your MDSAP journey.
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