Have your medical devices assessed for compliance and tackle the challenges of the EU-AI Act efficiently.
We’re offering up to 3 manufacturers a unique opportunity to receive a complimentary compliance assessment of their medical devices by students and supervised with Prof. Dr. Abächerli. This free assessment aims to guide you through the complexities of the EU-AI Act with a smart, efficient approach—minimizing risks, managing regulatory demands, and helping secure the future viability of your innovations.
Register here for the project presentation:
📅 Video Call on 18.11.2024, 16:00-17:00 with Prof. Dr. Abächerli
Register for the project presentation: Video Call on 18.11.2024, 16:00-17:00 with Prof. Dr. Abächerli – either by emailing info@colabon.com with the note "AI Project" or by filling out the contact form with the note "Videocall EU-AI Act and Medical Devices"; we will promptly send you the link to the videoconference.
Benefits for You as a Participating Manufacturer
Risk assessment for compliance with the AI Act for your medical devices
Understanding the new requirements and compliance costs arising from the AI Act
Avoidance of an MDR-like scenario through smart and efficient adaptation to the new regulations
Take this opportunity to have 1-3 of your products analyzed by dedicated students under the supervision of Prof. Dr. Abächerli. Together, we will develop practical solutions to keep your MedTech products compliant and market-ready.
Vision and Motivation #1: Why did Prof. Dr. Abächerli initiate this semester project?
Prof. Dr. Roger Abächerli aims to support MedTech companies through strategic planning and early action to mitigate the impact of the EU-AI Act on medical devices. The goal is to help manufacturers ensure the regulatory compliance of their medical devices, as these can only be marketed in Switzerland and the EU under strict conditions.
Specific cases and the resulting regulatory requirements need to be identified and implemented. A legal assessment of the EU-AI Act is essential for medical device manufacturers who want to market their products in Switzerland or the EU.
To achieve this, specific use cases must be identified and the corresponding regulatory requirements under the AI Act must be implemented. A thorough legal assessment of the EU-AI Act is indispensable for medical device manufacturers looking to distribute their products in Switzerland or the EU.
Applicability #2: Why must medical device manufacturers address the regulation on artificial intelligence (EU-AI Act)?
Automatic classification of medical devices as high-risk AI systems
With the publication of the EU-AI Act in June 2024 (Regulation (EU) 2024/1696), certain medical devices will automatically be classified as high-risk AI systems. For manufacturers of these products, it is crucial to understand and implement the new regulatory requirements.
Deadlines #3: By when must medical device manufacturers address the regulation on artificial intelligence (EU-AI Act)?
On June 13, 2024, the EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION published Regulation (EU) 2024/1689 on artificial intelligence (Artificial Intelligence Act). This regulation also applies to medical devices, with only a few exceptions in the classification.
As of June 13, 2024, Paragraph (179) of the EU-AI Act states the following regarding deadlines:
This Regulation should apply from 2 August 2026. However, taking into account the unacceptable risk associated with the use of AI in certain ways, the prohibitions as well as the general provisions of this Regulation should already apply from 2 February 2025. While the full effect of those prohibitions follows with the establishment of the governance and enforcement of this Regulation, anticipating the application of the prohibitions is important to take account of unacceptable risks and to have an effect on other procedures, such as in civil law. Moreover, the infrastructure related to the governance and the conformity assessment system should be operational before 2 August 2026, therefore the provisions on notified bodies and governance structure should apply from 2 August 2025. Given the rapid pace of technological advancements and adoption of general-purpose AI models, obligations for providers of general-purpose AI models should apply from 2 August 2025.
#4: Procedure and Timeline
Clarification of the AI Act’s Applicability to Your Medical Device
Reviewing whether and how the AI Act applies to your medical device (qualification).
Identification of Relevant ClausesDetermining which specific clauses of the AI Act are applicable to your medical device.
Understanding the ImpactAnalyzing the applicable requirements of the AI Act and their effects on your medical device to ensure regulatory compliance.
1–3 manufacturers will be supported until the end of November 2024.
The assessment will take place during the spring semester of 2025.
#5: Commitment to Collaboration
Provision of Relevant Information Manufacturers must provide the required data for their medical device (subject to an NDA).
Participation in Presentations Manufacturers are required to participate in interim and final presentations to monitor the progress of the assessment.
ColabON: Your Central Platform for Regulatory Requirements in AI Act and Medical Devices and Artificial Intelligence (AI)
A rapidly growing trend in the medical device industry is the increasing use of software and artificial intelligence (AI). With the introduction of the EU-AI Act, many manufacturers face the challenge of understanding the new regulatory requirements and integrating them into their processes. Since this regulation is still very new and its legal interpretation remains unclear, it is crucial for manufacturers to have a solid foundation to plan the next steps.
ColabON offers a centralized regulatory database where regulations like the EU-AI Act can be interpreted and commented on. This platform is continuously updated in light of the new regulation, which is expected to also apply in Switzerland.
Manufacturers of medical devices that wish to market their products in Switzerland or the EU must understand and implement the specific regulatory requirements of the EU-AI Act. A thorough legal assessment of the AI Act is essential. ColabON provides these assessments to all users of the platform, enabling the Swiss MedTech industry to benefit from an intelligent initial evaluation.
Start-ups, in particular, which increasingly rely on AI in their products and often lack the resources for comprehensive regulatory assessments in early development phases, can directly benefit from the published expert evaluations.
ColabON is a service provider specializing in quality management and regulatory affairs for the MedTech industry. In addition to MDR (Medical Device Regulation), ColabON offers extensive support in applying the EU-AI Act. Students and experts collaborate to perform digital assessments and evaluations to ensure the compliance of medical devices.
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