European healthcare undergoes a new CE marking approval process - determining when and the reasons behind it.

The European Union (EU) has introduced a new legislative framework for industrial products, including artificial intelligence (AI) systems. This framework, known as the EU AI Act, sets regulations for high-risk AI systems.

For high-risk AI systems, such as those used in biometrics, remote biometric identification systems, AI systems for biometric categorization, and AI systems for emotion recognition, third-party assessments are required. These assessments ensure the systems meet the necessary safety and performance standards.

When a notified body is involved, they assess both the Quality Management System (QMS) and the technical documentation, conduct periodic audits, and may require additional tests of the AI system. If the system does not meet the requirement relating to the data used to train it, retraining of the AI system may be required.

Affixing the CE marking is a provider's obligation under the regulation, but other operators must also verify its presence. The CE marking for high-risk AI systems must be affixed visibly, legibly, and indelibly, but it can be placed on the packaging or accompanying documentation if necessary. For high-risk embedded AI systems, a physical CE marking should be affixed (and may be complemented by a digital CE marking). A digital CE marking is required for high-risk AI systems provided digitally, and it should be easily accessible.

If a third-party assessment is not required, providers of high-risk AI systems can follow an "internal control" procedure. This involves verifying compliance of an established QMS with the EU AI Act's requirements, self-examination of the high-risk AI system's technical documentation, and controlling that the design, development process, and post-market monitoring of the high-risk AI system is consistent with the technical documentation.

The CE marking is necessary for high-risk AI systems to move freely within the EU's internal market. The CE marking is followed by the identification number of the notified body responsible for the conformity assessment procedures.

Notified bodies controlling the conformity of high-risk AI systems with the EU AI Act must comply with the EU AI Act's conditions on independence, professional integrity, and sufficient internal competence. In the pharmaceutical industry, the notified body responsible for conformity assessment is designated by the relevant national authority within the EU member state where the manufacturer is established.

Life sciences businesses that do not have CE-marked products in their portfolio will have to familiarize themselves with the new requirements for applicable high-risk AI systems when they act as providers. Businesses that only use or deploy high-risk AI systems without acting as providers are not in charge of CE-marking high-risk products but they will be required to familiarize themselves with the instructions for use accompanying each high-risk AI system they deploy.

The CE marking of conformity is required for high-risk AI systems to demonstrate compliance with the EU AI Act. This marking ensures that these systems meet the high standards of safety and performance required by the EU, providing consumers and businesses with confidence in their use.