MedQAIR’s AI Medical Device Regulation experts will ensure that your AI systems deployed within the European Union align with the mandatory requirements in the AI Act (2024/1689)
On the first of August 2024, after 3 years of development, the AI Act entered into force. The AI Act (2024/1689), similar to the Medical Device Regulation (MDR) and the In-Vitro Medical Device Regulation (IVDR), the Machinery Regulation, and so on, is a Product Legislation following the European New Legislative Framework (NLF Legislation).
As experts in the medical devices field, having been regulated through NLF for quite some time, we understand what is needed to implement the AI Act within organizations developing products considered High-Risk under the AI Act.
Navigating the rapidly evolving landscape of AI in medical device manufacturing is critical. With new legislation implemented, medical device manufacturers integrating AI systems—whether in core products or as complementary tools—must adapt to remain compliant. Failure to adhere to this artificial intelligence regulatory compliance could result in significant compliance debt, incurring substantial costs and setbacks. Preparation is key to ensuring smooth compliance and sustaining innovation in this high-stakes industry.
Our responsible AI team integrates technical, legal, and business expertise to navigate the complexities of evolving technology and law. We offer professional advice and managed services to help you explore AI opportunities while effectively managing associated risks.
The main requirements for the AI Act to demonstrate compliance are a) the implementation of a Quality Management System and b) Technical Documentation that demonstrates how the requirements for High-Risk products are being fulfilled. Suppose your product is regulated today under the New Legislative Framework (e.g. medical devices). In that case, you can incorporate these requirements into your existing Quality Management System and Technical Documentation to demonstrate compliance as clarified in the AI Act.
At MedQAIR we can support the implementation of a Quality Management System from scratch, e.g. per ISO 42001, considering that it needs to demonstrate compliance with the AI Act since ISO 42001 might not be harmonized under the AI Act. Or we can support upgrading your ISO 13485 Quality Management System to meet the requirements of the AI Act in anticipation of an additional standard that may be harmonized in the future.
Similarly, we can support organizations in building up their Technical Documentation to demonstrate compliance with the requirements set out in the AI Act or upgrade existing Technical Documentation.
Once your Quality Management System is implemented, and the Technical Documentation demonstrates compliance with the requirements for High-Risk AI Systems, the final step will be to update the Declaration of Conformity and claim compliance with the respective legislation. If you manufacture medical devices, this may account for a significant change where the Notified Body will want to review the upgraded technical documentation before you can sign off on the Declaration of Conformity.
As an experienced EU Authorized Representative with a team of qualified experts, MedQAIR has been assisting non-European manufacturers of medical devices and in-vitro diagnostic medical devices in successfully marketing their products across the European Union. Now, with AI solutions falling under the medical device industry's need to comply with the AI Act (2024/1689), manufacturers of AI systems should seek expert consultants to navigate the complexities of the law and regulations.
Our consultants are highly knowledgeable about current standards for software medical devices and those powered by AI, including deep-learning technology. Our comprehensive approach guarantees that your product meets all EU medical device and artificial intelligence regulations, including safety, labeling, and other requirements.
The European Union’s (EU) AI Act is a regulatory framework, which entered into force on the 1st of August 2024It is designed to ensure that developed AI systems align with the core values of the European Union. The framework establishes requirements for AI across the EU, creating a unified market for AI applications. It establishes standardized rules for bringing products to market and is recognized by the European Parliament as the world’s first comprehensive AI law. The Act places obligations on AI stakeholders worldwide if their AI is used or developed within the EU, thereby shaping global AI practices to align with EU standards.
The act was published in the Official Journal on July 12 and will come into force on August 2. Requirements for high-risk devices listed in Annex I (including medical devices) per Article 6(1) will come into effect on the 2nd of August, 2027.
The adoption of artificial intelligence (AI) in medical devices has surged in recent years, becoming a key element in MedTech development. AI systems excel at analyzing vast amounts of data and detecting patterns, which enhances diagnostic technology and patient care.
However, this advancement also brings up legal and ethical concerns. To address these issues, the European Union has introduced the AI Act, the first regulatory framework for artificial intelligence, which significantly impacts the medical device sector..
The AI Act defines an AI system as “a machine-based system designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments”.
In simple terms, it broadly defines an AI system as any system that, with a degree of autonomy, infers inputs to determine how to produce outputs (such as predictions, recommendations, decisions, or content) that can impact physical or virtual environments.
The EU AI Act applies to various operators within the AI value chain, including providers, deployers, importers, distributors, product manufacturers, and authorized representatives.
Notably, the Act provides specific definitions for providers, deployers, and importers.
When this law is fully enacted, developers of AI-based medical devices and components will need to comply with an additional set of requirements. These new regulations for AI systems will supplement the existing requirements under the EU’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).
Notified bodies responsible for conducting conformity assessments under MDR and IVDR will soon have an extra set of regulations to oversee. Notified bodies will need to ensure they have the right expertise in-house to ensure they can assess medical device companies against the requirements of the AI Act. Moreover, Notified Bodies will need to ensure they are capable of testing AI systems, based on the training, validation, and testing data being made available by the manufacturer to the Notified Body, along with the relevant algorithms.
Explore in-depth insights into MDR, IVDR, and AI Act compliance.
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