By virtue of the document, the EC will implement a new regulation that will address all matters related to AI-based products. The authority acknowledges the increasing importance of this technology and also the need for a clear and efficient regulatory framework to be introduced. Further development of AI-based medical devices could provide additional benefits for patients. At the same time, it is important to ensure such devices meet safety and performance requirements, which require certain improvements due to the unique features of AI-based products resulting from the specifics of the technology itself. Thus, a balanced approach is required. The document reflects the principles initially announced in the White Paper on AI published by the EC earlier in February 2020. The aforementioned document describes an approach that balances the creation of a favorable regulatory framework encouraging further development of AI-based products with the need to ensure that associated risks are duly mitigated.
The new regulation is intended to introduce a harmonized framework for AI-based medical devices in order to ensure their safety and effectiveness, together with data protection, when applicable. In particular, the European Commission outlines the following goals of the new regulation:
– Ensuring the safety of AI-based products,
– Improving legal clarity of the regulatory framework,
– Making existing regulations more effective,
– Encouraging and facilitating further development of AI technology.
For this purpose, the EC intends to introduce a balanced regulatory approach reducing the regulatory burden to the lowest extent possible regarding the safety-related aspects to simplify the procedures to be performed to place AI-based medical devices on the market. The authority expects the suggested risk-based regulatory approach to be flexible enough to reflect the current needs of this emerging sphere. In particular, it provides the definition of artificial intelligence and also distinguishes its permitted and prohibited use. Once the new regulation becomes effective, any and all medical devices based on the use of AI technology should comply with the regulatory requirements set forth therein in order to be allowed for marketing and use in the European Union.
The authority additionally emphasizes that the obligations of the medical device manufacturers should be clear and predictable – this will encourage further development of medical devices employing novel technologies. It is also stated that additional steps will take place, namely:
– Establishment of a European Artificial Intelligence Board,
– Regulatory sandboxes for AI-based products,
– Special support programs for start-ups engaged in the development of AI-based medical devices.
The document also describes in detail the way the new regulation would correspond to existing legislation. It is important to mention that the actual scope of application of the proposed regulation exceeds the healthcare sphere and covers any use of AI-based products.
The proposed regulatory framework encourages moving the focus from national to international rules and requirements. As stated in the document, regulation by means of national legislation will only create additional complications, while international cooperation of all Member States will improve the effectiveness of the mechanisms necessary to ensure the proper balance between safety and availability of AI-based products. This becomes especially important in terms of international trade and open markets.
As was mentioned before, the new regulatory framework employs a balanced risk-based approach intended to improve transparency and remove the unnecessary regulatory burden medical device manufacturers can face nowadays. However, the regulatory requirements to be applied for high-risk AI-based products would remain quite strict in order to ensure the safety of such products. Due to the specific features of AI-based products, additional attention should be paid to the accuracy of data used to improve the operations of the products. The authority additionally emphasizes the important role to be played by harmonized standards and additional guidelines dedicate to compliance matters – they should become a valuable source of information to be used by the manufacturers for ensuring compliance with the applicable regulatory requirements.