The EU AI Act adds another layer of questions for companies developing AI-enabled medical devices and in vitro diagnostic devices. This article reflects the discussion around the European Parliament’s June 2023 draft, alongside the EU Medical Device Regulation (MDR), which began applying in May 2021. It is historical background, not a statement of the AI Act’s current legal requirements or implementation dates.

Industry groups raised concerns about how the proposed AI rules would interact with existing MDR and IVDR requirements. For companies working with medical devices, that interaction remains an important topic when planning product development and regulatory review.

Questions Raised by the Draft AI Act

The 2023 parliamentary draft took a risk-based approach to AI systems. One question for medtech developers was whether an AI component used in a medical device or in vitro diagnostic would trigger high-risk AI requirements as well as MDR or IVDR obligations. The original article discussed a draft recital concerning products that require a notified body during conformity assessment. Because this was a draft, its wording should not be treated as a final classification rule.

Applying multiple frameworks could affect documentation, conformity assessment, risk management and oversight. Industry participants also discussed how the proposed AI framework might interact with product-liability rules and with updates to machine-learning software. Those questions should be assessed against the applicable rules in force for a particular product, rather than assuming every AI-enabled device follows the same pathway.

The original article linked a pregnancy and ovulation monitoring collection in this discussion. That collection is not evidence that its products contain AI or fall within a particular regulatory category.

Practical Preparation for Medtech Teams

Teams developing AI-enabled products can begin by documenting each AI component’s intended use, its role in the device, potential risks, data practices and change-control process. They should then assess which current MDR or IVDR provisions and AI-specific obligations apply to that product. Safety, reliability, transparency and human oversight require product-specific consideration, not a generic certificate claim.

Regulatory plans also need to account for revisions to software and for the relationship between the AI system and the medical device as a whole. Legal and regulatory specialists should confirm the applicable dates and conformity-assessment route using current official EU texts before a product is marketed.

Looking Ahead

The 2023 draft prompted useful questions about the overlap between AI governance and medical-device regulation. Its proposals were part of a legislative process, so the article’s original forecasts about transition periods and automatic classifications should not be presented as current law. For OEM enquiries about MDR or IVDR products, contact insights@medasiagroup.com.