Due to their complexity and their innovative aspects, the integration of requirements for “combined products” for a single market represents a challenge for companies, and an even higher challenge when several different market are targeted. The launch of the MDSAP program allowing the conduct of a single audit through the integration of the requirements of five regulatory jurisdictions highlighted some elements in the audit process (despite the fact that differences remained on the way those products are recognized in the different jurisdictions). In Europe, while the auditing approach of those products tended to be harmonized among Notified Bodies under the MDD, differences could sometimes occur due to different national regulatory considerations. With the new MDR, the requirements for those products have been amended to include products outside of the scope (Article 117) and add new requirements. This session aims to highlight the main similarities and differences in auditing process through different regulatory perspectives.