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Team-NB issues position paper discussing Notified Bodies under upcoming EU AI Act

Published by Alec Denniff, Medical Device Paralegal on

Team Notified Body (Team-NB) – the European Association of Notified Bodies active in the medical devices sector – has issued a position paper addressing the designation of Notified Bodies under the upcoming EU Artificial Intelligence (AI) Act. 

The Proposed AI Act

We previously reported on how the new EU AI Act will impact medical devices on the EU market. The Act will cover artificial intelligence systems (broadly meaning any software developed using machine learning, logic/knowledge-based, or statistical approaches that can generate outputs for a given set of human-defined objectives). The proposed AI act will inevitably have consequences for the medical devices industry, as AI algorithms, machine learning, deep learning etc. continue to gain popularity in the healthcare sector. Such technologies are forging new trends, particularly as they support healthcare professionals by automating complex and traditionally lengthy processes. As the benefits of such technologies continue to break boundaries and create further efficiencies in accurate diagnosis, therapy, and the facilitation of personalised treatments, they will attract increasing regulatory requirements.

Whilst many medical devices which utilise AI have already been approved, the European Commission is conscious of the fact that the regulatory pathways provided in the EU Medical Devices Regulations do not address the rapidly changing nature of AI technologies. In light of this, the proposed AI Act is a horizontal regulation, laying down a risk-based approach where AI-enabled systems are categorised based on their level of risk. It will apply to any medical device which involves an element of AI, regardless of whether the AI system is placed on the market as an incorporated component of a device, or as a medical device in and of itself. 

Following the risk-based approach used in the proposal, all medical devices AI systems which are required to undergo a third party conformity assessment are to be classified as ‘high-risk’. This means that medical devices in Class IIa and above and in-vitro diagnostic devices in Class B and above will be deemed ‘high-risk’ under the AI Act and must comply with additional obligations. In comparison, Class I devices and Class A IVDs devices (which do not have to undergo a Notified Body conformity assessment) will generally be considered low or minimal risk.

Team NB’s Position Paper

Any AI system which is deemed ‘high risk’ will be required to undergo an additional Notified Body conformity assessment procedure to establish conformity with the requirements of the AI Act. Team-NB’s position paper highlights the challenges which are to be expected in the designation of Notified Bodies under the AI Act. In particular, the position paper notes that the augmentation of the existing competence of EU MDR/IVDR Notified Bodies will not be possible. This might come as a surprise to MDR/IVDR NBs, some of which have already started developing approaches to assessing medical devices and IVDs with AI. 

This will mean that MDR/IVDR NBs will have to follow the designation process outlined in the proposed AI Act. MDR/IVDR designated NBs will need to apply for notification as per Article 31 of the AI Act. In addition, they will need to comply with the requirements of Article 33, which lists 12 conditions for NBs to be able to assess AI driven devices (e.g. competence, organisational structure, resources, etc). 

Team-NB’s position paper highlights the serious implications this might have. Firstly, it would mean that manufacturers of AI driven devices which are already on the market will struggle to find designated NB's who are able to process their change requests. It would also mean that new manufacturers of devices with AI technology will not be able to enter the EU market until NB's have been designated. Team-NB also note that these implications have further undesirable impacts on the already stretched capacity of EU MDR/IVDR NB's, who will need to invest more resources and time towards the new designation process rather than building internal competences for the assessment of AI in medical devices. 

Instead of having to undergo a completely new designation process, Team-NB has outlined their recommendations for the best way forward. Recognising that, while there is agreement among Team-NB members that additional technical expertise on AI is required during to carry out conformity assessments, a better alternative would be to up-skill already designated NB's under the MDR and IVDR so that they can accommodate AI. This process is already mandated by the MDR/IVDR, which requires that NB's update their resources, personnel competent, processes and skills (Annex II Section 3 and 4 MDR/IVDR). As stated above, many NB's have already begun implementing authorisation procedures to accommodate technical changes in state-of-the-art. Where specific technical expertise on certain AI requirements is needed, Team-NB recommends that additional codes/scopes of competence for AI under the MDR/IVDR should be introduced. 

Team-NB notes that this approach would also be consistent with recommendations outlined MDCG 2022-14, which highlights the current challenges industry are experiencing in the MDR/IVDR transition. In particular, recommendation nine of MDCG 2022-14 states that the MDCG will explore means to add additional codes for the designation of NBs. AI-specific codes may be the best way forward to define those MDR/IVDR designated NB's who can assess devices with AI. 

Manufacturers of medical devices with AI (whether already on the market or in development) should take note of the proposed AI-Act. Manufacturers in the former category should also be in discussions with their NB regarding whether they will be competent for AI or whether they plan to be qualified for AI technologies. 

How we can help

If you are currently unsure on the classification of your medical device or IVD under the MDR/IVDR, and how this might affect your obligations under the proposed AI-Act, please contact any member of our team or register your interest below. Our Regtik platform can help you figure out the classification of your device, and what rules will be applicable to you under the proposed AI-Act.