Post by DEKRA Certification

AI Act for Medical Devices: The Deadline Moves to 2028 — Readiness Doesn’t.   Following the political agreement on the AI Omnibus package, proposed by the European Commission to simplify implementation of the EU AI Act and reduce administrative burden, the application date for high-risk AI systems embedded in regulated products including medical devices, is expected to move to 2 August 2028.   While the legislation still requires formal adoption and publication, the direction of travel is now clear. For manufacturers, this offers valuable additional preparation time, but it should not be interpreted as a reason to slow down readiness activities. Instead, it is an opportunity to prepare in a more structured and strategic way.   Key priorities include: 👉 Clarify how the AI Act applies to your portfolio and its interaction with MDR and IVDR 👉 Adapt QMS, development and risk management processes for AI-specific requirements (data governance, transparency, human oversight, lifecycle monitoring) 👉 Align technical documentation with AI Act expectations (system description, performance evaluation, data governance, post-market monitoring) 👉 Strengthen AI governance: roles, responsibilities and oversight 👉 Identify competency gaps, particularly in AI/ML lifecycle management, AI-specific risk management, data governance, human oversight and regulatory requirements 👉 Consider how risks relating to bias, discrimination, transparency and other fundamental rights aspects are identified, assessed and controlled 👉 Track emerging harmonised standards, common specifications and regulatory guidance   📌 Bottom line The expected shift to 2 August 2028 creates valuable breathing space, but not a pause button. Organizations that use this time to strengthen processes, governance and documentation will be significantly better positioned when requirements fully apply. From a Notified Body perspective, the message remains consistent: Start early. Build steadily. Be ready.   #AIAct #MedicalDevices #MDR #IVDR #ArtificialIntelligence #RegulatoryAffairs #QualityManagement #Compliance #MedTech #NotifiedBody