Call to manufacturers: Enabling European regulator observation of combined MDSAP–MDR/IVDR Audits

Posted on 02.07.2026

The MDSAP Forum was held in Kyoto, Japan between 15 -19 June 2026. Medical Device Single Audit Program (MDSAP) is currently chaired by US FDA until 2028. Day 2 and 3 of the Forum were open to industry and other stakeholders. MedTech Europe was represented during both days.

During the sessions, regulators provided several updates on their activities. Of particular note, is the growing interest from regulators in the program, with several regulators exploring combined MDSAP audits with their respective regulations, and others expressing interest in becoming members of the MDSAP Regulatory Authority Council (i.e., UK and Korea).

The European Union was well-represented and provided thorough updates on the EU engagement on MDSAP-related activities. In particular, updates were provided on the status of MDSAP-MDR/IVDR mapping and on the development of a Single MDSAP/MDR-IVDR Report template. Overall, these efforts will still require time and information gathering. Industry can support these efforts by offering the possibility to the EU Commission and Competent Authorities to observe planned MDSAP-MDR/IVDR audits. This would strongly support EU’s efforts and help accelerate progress. In case of interest, you are welcome to contact the MedTech Europe Secretariat: Diana Kanecka, Director International Affairs and Alice Bova, Senior Officer International Affairs.

Finally, MDSAP announced the creation of an MDSAP industry group gathering industry representatives of the 5 MDSAP RAC members (i.e., US, Australia, Canada, Brazil, and Japan), each represented by the respective industry associations. At this point, MedTech Europe is not part of this industry group given the current EU’s status as official observer in the programme.