Summary of recommendations
COCIR recommends that manufacturers of an AI-based system that changes through learning during runtime add a pre-determined Algorithm Change Protocol to the technical documentation of their device for evaluation during conformity assessment. Manufacturers that make significant changes to the pre-determined Algorithm Change Protocol need to update the technical documentation, including the clinical evaluation. They need to perform a new conformity assessment. Changes that are in scope of the Algorithm Change Protocol are not significant changes. Changes that go beyond the change of the Algorithm Change Protocol can be significant. COCIR recommends that manufacturers of an AI-based system that changes through learning to consider a design capable of storing discrete states of a learned model and capable of returning to a previously stored state in order to reproduce results. COCIR recommends citing in the Official Journal of the European Union relevant AI standards for EU MDR and EU IVDR as they become available. This will further the common understanding, the transparency, and the trust between stakeholders. Explicability is a means (to trust), not a goal. Rather than legislators issuing a blanket requirement for all AI to be explained, COCIR suggests that, in alignment with EU MDR and EU IVDR, AI to be made transparent to the point of becoming actionable to the user, if required to ensure the safe and effective use of the device. Also in alignment with EU MDR and EU IVDR COCIR recommends manufacturers to “minimize bias”, rather than obtain “zero bias”, as COCIR considers the latter to be impossible […] .COCIR analyses application of medical device legislation to Artificial Intelligence
COCIR. “COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007.COCIR is unique as it brings together the healthcare, IT and telecommunications industries.Our focus is to open markets for COCIR members in Europe and beyond. We provide a wide range of services on regulatory, technical, market intelligence, environmental, standardisation, international and legal affairs.COCIR is also a founding member of DITTA, the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (globalditta.org)” (Source: cocir.org/about-cocir.html).