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Ensuring compliance for AI-based medical devices

Are you prepared for regulatory changes?

AI-based medical devices have the potential to transform healthcare by providing enhanced diagnostic capabilities, personalised treatment options, and improved patient outcomes. However, navigating the strict regulatory framework established in the EU, comprising the EU Medical Device Regulations (EU MDR) and the forthcoming EU AI Act, is essential to ensure safe and effective diagnosis and treatment, while safeguarding patient privacy, trust and fundamental rights.

Manufacturers of these innovative devices face the dual challenge of complying with these regulations while fostering continuous innovation in this rapidly evolving field. To assist manufacturers in this journey, we offer comprehensive support in conducting compliance readiness assessments of their Quality Management System (QMS) and Technical Documentation against the requirements and standards of both the EU MDR and the forthcoming EU AI Act.

Our structured assessment process encompasses all relevant stages of the device lifecycle, including software and AI model development, testing and release, as well as post-development monitoring activities. By conducting this assessment, we can clearly determine whether the expectations of the EU MDR are fulfilled and whether the complementary requirements of the EU AI Act are adequately addressed.

The outcome of our assessment will provide an overview of the current state of compliance, identify any gaps and deviations from applicable requirements, and highlight areas for improvement. Additionally, we will offer a detailed action plan for remediation and a roadmap guiding manufacturers toward compliance and the achievement of the CE mark.
 

Assess your AI medical devices for regulatory readiness
 

The main provisions of the AI Act will apply from 2nd August 2026, with the specific requirements and obligations for AI-based medical devices following on 2nd August 2027. While this may seem distant, early preparation is essential for success.

Manufacturers are strongly encouraged to begin identifying and assessing the impact of the complementary requirements outlined in the AI Act. To ensure consistency, prevent duplication, and minimise additional burdens, it is advisable to integrate the necessary information and documentation into their existing QMS and Technical Documentation that already comply with the EU MDR.

At Deloitte, we have dedicated experts who can help you navigate the regulatory complexities surrounding AI-Based medical devices. Together, we can harness the complete capabilities of your innovations in healthcare. Please reach out for further information.

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Our thinking

Navigating EUDAMED implementation

'Navigating EUDAMED Implementation' is a must-read for medical device manufacturers adjusting to the European Medical Device Regulations (EU-MDR, EU-IVDR). EUDAMED go-live might seem far away, however, it is crucial to realize that there are many complex tasks that need to be executed before this time. Manufacturers face the challenging job of carefully improving their processes, preparing the organization, their technology, and information landscape. This involves a lot of effort and time, especially because it is important to take a thorough and proactive approach to make sure that you can successfully comply with EUDAMED requirements. Start your EUDAMED compliance journey today.
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Aida Demneri

Partner
+31882880018

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