Brussels, 18 March 2024

With the recent endorsement of the AI Act by the European Parliament, COCIR continues to offer input from the medical technology industry sector. Artificial Intelligence (AI) in healthcare is a reality and has brought improvements for patients, professionals, providers, and other healthcare stakeholders as well as society at large. Many have embedded the technology into their workflows and decision-making process. The adoption of the Artificial Intelligence Act (AIA) will potentially impact the availability of AI-based medical devices in the EU market due to overlaps with existing legislation regulating the medical device sector.

The Complex Landscape of Regulatory Requirements

The AIA introduces additional requirements for AI-based devices, which can be integrated into the existing conformity assessment procedures under the MDR. The overlap of these legal regimes, compounded with those regulated by the digital laws (such as the Data Act), leads to inconsistencies, duplications, and uncertainties, ultimately delaying the delivery of products to patients and posing significant barriers to innovation in the EU.  Key challenges are:

1. Conformity Assessment
a. Sectoral Legislation Ambiguity: AIA and sectoral legislation are not aligned on crucial terminology and obligations. Alignment issues at legislative level risk propagating into contradictory and inefficient implementing measures (procedures, guidance, templates, standards, etc.).
b. Notified body involvement during conformity assessment. AIA demands conformity assessments for each substantially modified high-risk AI system, differing from the MDR's “significant change” concept, and sampling principles, impacting the availability of AI-based devices in the market.
c. Increased costs of development and placing medical devices on the EU market: The end-to-end costs of medical innovation in the EU, already raised with the implementation of the MDR, will further increase due to the need to navigate the increasingly complicated and convoluted regulatory environment.

2. Clinical investigations and performance studies
Different definitions for the terms “placing on the market”, “making available on the market” and “putting into service” may potentially render clinical investigations and performance studies of AI-enabled medical devices illegal.

3. Duplication of Registration Requirements
Manufacturers of medical devices with an AI system that qualifies as a biometric categorization system must register twice, in EUDAMED and a yet-to-be-established AIA database, introducing further administrative inefficiencies.

4. Incompatible standards and guidance
Due to differences in terms, definitions, and obligations, standards and guidance may be developed for the AIA thereby aggravating incompatibilities with medical device sector legislation, its guidance and its harmonised standards.

COCIR’s Key Concerns

1.  Conflicting requirements in risk management: The AI Act introduces requirements, such as risk management and conformity assessment procedures, that clash with existing elements of MDR. MDR already ensures patient safety aspects of medical devices.
2. Duplication of Conformity Assessments: Notified bodies will have to go through parallel processes for quality management systems and post-market surveillance. This may result in additional conformity assessments, documentation sets, and incompatible harmonised standards for each device. This may significantly constrain Notified Bodies.
3. Capacity of Notified Bodies: The responsibilities of notified bodies under the AI Act, coupled with MDR, will be resource-intense, further delaying access to medical devices in the EU market.
4. Impacts on Healthcare Systems and Economy: Impacts may include extended certification procedures, increased development costs, prioritization of other markets, and diversion of resources from research and development. This will ultimately lead to reduced access to safe medical technologies to EU citizens and patients.

COCIR Recommendation

• We ask for effective alignment mechanisms between the AI Board, Medical Device Coordination Group, and stakeholders in the upcoming implementation of AIA which ensure safety, performance, and effectiveness of AI-enabled Medical Devices.

As the EU navigates this regulatory landscape, the alignment between the AIA and MDR is crucial to ensure patient safety, foster innovation and maintain a robust medical device industry in Europe. The collaborative efforts of regulators, manufacturers, and stakeholders are essential to solve these challenges and pave the way for a harmonised and effective regulatory framework. COCIR is committed to engage in a constructive dialogue with policy makers and stakeholders to overcome any barriers to the availability of AI-based medical devices to patients and healthcare systems.