MDCG guidance clarifies requirements for AI products under AI Act, MDR, and IVDR

The European Commission’s Medical Device Working Group (MDCG) has published a guidance outlining how the Medical Device Regulation (MDR), In Vitro Diagnostics Regulation (IVDR), and the recently enacted Artificial Intelligence Act (AIA) interplay when applied to certain artificial intelligence (AI) products. The guidance details expectations on how manufacturers should address risk, conformity assessments, and predetermined changes to the products.

The frequently asked questions and answers document aims to help manufacturers understand their responsibilities under the three European texts. It also clarifies terms used under the different texts and discusses legal requirements, clinical and performance testing, conformity assessments, and more.

An important aspect of the guidance is that it delves into how risk is defined by the legislations and what that means for manufacturers who want to market their products in the EU. It states that medical device artificial intelligence (MDAI) products are considered high risk if they have a safety component or their AI system is regarded as a medical device. The product must also be subject to a third-party conformity assessment under MDR or IVDR.

Just because a device is classified as a high-risk device under AIA doesn’t mean it is a high-risk device under MDR or IVDR.

“It is rather the classification of a medical device under the MDR/IVDR which determines whether the AI system qualifies as high-risk under Article 6(1) AIA (refer back to Q2),” said MDCG. “The classification of MDAI under the MDR or IVDR determines the applicable legal requirements for high-risk AI systems under Article 6(1) AIA and therefore impacting the regulatory scrutiny and oversight required for the high-risk MDAI.”

MDCG added that all legislation requires manufacturers to implement a continuous and iterative risk management system throughout the product's lifecycle in pre- and post-market settings. The working group added that the legal requirements are meant to ensure stakeholders can identify and mitigate risks.

"Risk management requirements specific to high-risk MDAI include ongoing assessments of known and reasonably foreseeable risks that the high-risk MDAI can pose to fundamental rights, data biases, and system robustness, including identification, analysis, and mitigation of risks related to system design, development, and deployment, and may include training to deployers," said the guidance. "This includes measures to ensure the safety and reliability of high-risk MDAI in healthcare settings through comprehensive risk assessments, documentation of risk mitigation measures, and continuous monitoring of system performance."

The guidance further notes that high-risk MDAI manufacture may be required to meet additional risk management requirements under the AIA.

MDCG also touches on quality management in the guidance and states it is crucial to ensure MDAIs are safe and perform as intended. Under MDR and IVDR, manufacturers are directed to establish, document, implement, maintain, keep up to date, and continually improve their quality management systems proportional to their device's risk classification.

MDCG noted that providers and manufacturers are required to also implement quality management systems for AI systems under AIA.

“The quality management system required under the AIA covers substantive requirements, procedural obligations and at least thirteen aspects, to be implemented in a proportionate manner according to the size of the provider’s organization,” said the guidance. “Similar to the MDR / IVDR, this includes a strategy for regulatory compliance, the documentation of a quality management system, which should encompass written policies, procedures, and instructions regarding aspects such as risk management and performance testing.

“The quality management system obligations under the AIA are specifically targeted to the AI system,” the guidance added. “Therefore, the AIA requirements are complementary to the quality management system required under the MDR or IVDR and applicable to the overall MDAI.”

Another important question addressed in the guidance is whether the type of substantial modifications under the AIA will be aligned with changes that could require a new conformity assessment under MDR or IVDR. MDCG noted that high-risk MDAIs under the AIA must undergo a new conformity assessment if the product has been substantially modified.

The working group also clarified that if a high-risk MDAI undergoes changes that are pre-determined and assessed during the initial conformity assessment, the changes would not be considered substantial modifications. It further stated that such changes should not be considered as a change to the certified medical device or in vitro diagnostic (IVD) under MDR or IVDR.

“It is essential that at the time of conformity assessment, the pre-determined changes must be clearly specified and adaptable to the device's evolving nature,” said the guidance. “This performance, documented in the technical documentation, should include a detailed description of the initial performance expectations alongside mechanisms for validating and managing changes that occur post-market.”

MDCG guidance

MDCG guidance clarifies requirements for AI products under AI Act, MDR, and IVDR

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