Regulation (EU) 2024/1689 (AI Act) is set to be fully implemented for products falling within the scopes of both Regulations (EU) 2017/745 on medical devices or 2017/746 on in vitro diagnostic medical devices (MDR or IVDR) respectively and the AI Act within three years of its publication in the Official Journal of the EU (OJEU).
The date of publication was July 13 and the date of entry into force of the AI Act was August 2, 2024. The latter date marks the beginning of the aforementioned three-years transition period. We have added a brief summary of the main transitional stages:
Date | Provision |
---|---|
02 February 2025 | Provisions on prohibited AI systems apply (Chapters 1 and 2) |
02 August 2025 | Provisions on general-purpose AI models and further rules apply (e.g. Chapters III, V, VII) |
02 August 2026 | Provisions for annex III high-risk AI systems apply (remaining AI Act except Art. 6(1)) |
02 August 2027 | Art. 6(1) applies (Annex I high-risk AI systems including medical devices and IVDs) |
It is imperative to comprehend the entities affected by the new AI Act, discern the areas of convergence and disparity with the MDR and IVDR, and acknowledge the implications for manufacturers in the medical technology sector.
The initial factor to consider is whether the AI Act, based on a risk-based approach, is applicable to a product, and to do this, manufacturers need to:
- Read the AI Act’s recital 12 to comprehend the distinctions between AI systems and traditional software systems.
- Manufacturers should always keep in mind that medical devices and IVD products are typically classified as high-risk systems, irrespective of whether AI is integrated into a hardware medical device or used as a standalone technology.
- The AI Act’s article 6 outlines a two-step process for determining if a medical device qualifies as an AI system, which is a crucial step in understanding the AI Act’s applicability to a product.
- If the product is classified under article 6.1 and serves as a safety component for the product or AI system or is listed in annex I (including MDR and IVDR) and has undergone a conformity assessment (with the exception of class I devices under the MDR or IVDR), then it qualifies as an AI system.
- In the health sector, it is important to review article 6.2 and assess if the product is covered by annex III of the AI Act, which includes various systems such as private and public healthcare systems, hence qualifying as an AI system.
The good news is that manufacturers can streamline compliance by using a single system for both regulations (AI Act and either MDR or IVDR) and obtaining the services of a notified body for AI conformity assessments. Additionally, there are significant overlaps between the AI Act’s definition of providers and the concept of manufacturers under the MDR and IVDR.
The MDR and IVDR bring new obligations for providers, but some basic processes and documents such as quality management systems, design control, risk management, post-market surveillance (PMS), vigilance, and declaration of conformity remain the same. The AI Act enhances these processes with new provisions, such as data management, technical specifications, standards, and controller logs.
Providers of high-risk AI systems must prepare technical documentation according to annex IV of the AI Act, including device description, risk management, and labelling. Specific considerations include aspects such as drafting design specifications, disclosing the general logic and algorithms of the AI system, providing training methodologies and technologies, and others.
Stakeholders will also be delighted to hear that the AI Act states allows for one combined CE marking and declaration of conformity to demonstrate conformity to both MDR or IVDR and the Act.
Source: Medtech Insight (an Informa product)