The reality for manufacturers of medical devices with AI-based software has shifted noticeably in recent months. Originally, the high-risk requirements of the EU AI Act were set to apply to product-integrated systems such as Software as a Medical Device (SaMD) as early as August 2027. The "Digital Omnibus on AI," adopted at the end of June 2026, has pushed this deadline back to August 2, 2028.
Anyone already grappling with the Medical Device Regulation (MDR) and/or the In Vitro Diagnostic Regulation (IVDR) has often perceived the EU AI Act as yet another bottomless pit. That's understandable, but with good planning it's more manageable than many fear.
Four questions are currently occupying IT leadership and regulatory affairs teams in medtech in particular.
The postponed deadline provides lead time, but it's not an all-clear. The gap analysis, the expansion of the quality management system, and coordination with the Notified Body remain labor-intensive and tie up capacity for months.
Anyone who treats this extra time as a pause risks exactly what they were trying to avoid: additional audit loops, avoidable rework in the certification process, and delayed approvals.
Clinical trust is a resource that's harder to build than to lose. Competitors who tackle their integration early secure an advantage in the form of shorter approval cycles and more stable audits. Companies that only address integration shortly before 2028 will find themselves facing audit gaps that can't be closed overnight, since AI-specific requirements take time to become genuinely anchored in existing processes.
The MDCG 2025-6 guidance from the Medical Device Coordination Group (MDCG) has made clear since June 2025: MDR/IVDR and the AI Act are complementary legal frameworks that can be merged into a single QMS. The Digital Omnibus on AI further confirms this integrated approach.
For manufacturers, this means: they expand their existing ISO 13485 system with AI Act-specific processes based on ISO/IEC 42001. A gap assessment as a starting point shows which MDR processes already cover AI Act requirements and where expansion is actually needed. This requires initial effort for training and process adjustment. However, this effort lays the foundation for substantial savings compared to running two parallel systems.
sepp.med supports medical device manufacturers with exactly this integration:
Yes. In the event of a significant change to your product or recertification after the respective deadline, your SaMD must be AI Act compliant.
No. The MDCG 2025-6 guidance and the Digital Omnibus call for integration into your existing ISO 13485 QMS, not the creation of a separate system.
For product-integrated high-risk AI such as SaMD, August 2, 2028 applies. Standalone high-risk AI systems under Annex III are already affected as of December 2, 2027.
During the transition phase, the existing MDR/IVDR designation is generally sufficient. Nevertheless, clarify early with your Notified Body how it will implement the integrated assessment and what timeline applies.
Not automatically anymore. The definition of "safety component," refined by the Digital Omnibus, now requires a case-by-case review, even though many SaMD in classes IIa through III will continue to fall under it.
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