Over the past year, the discourse around Artificial Intelligence (AI) and its potential dangers has permeated public dialogue, emerging as a dominant theme in discussions on emerging technologies; this is the context where the AI Act was developed.
The initial blueprint for the Artificial Intelligence Act (“AI Act”) was unveiled by the European Commission in April 2021, following the release of a white paper in February 2020 and a series of specialized studies. The journey of the AI Act through the legislative pipeline has been marked by several milestones, including the presentation of a revised draft by the Council of the EU in November 2022. Currently, the AI Act finds itself amid the intricate negotiations of the trialogue procedure, adhering to the established legislative framework of the EU.
Within 4EasyReg website we have somehow already discussed topics related to artificial intelligence for medical devices, in particular discussing about the challenges of digital health technologies, the FDA Pre-Cert Program to support digital health devices and artificial intelligences within medical devices.
In this article, we will deal with new AI act issued by European Commission and the link with medical device technologies.
AI Classification according to AI Act
The proposed AI Act defines as high-risk any AI system meeting the following dual criteria:
Firstly, the system is designed for integration as a safety component within a product or constitutes a standalone product falling under the purview of EU harmonization legislation outlined in Annex II.
Secondly, the product incorporates an AI system safety component or embodies an AI system itself, thereby necessitating third-party compliance evaluation prior to market placement or service initiation, aligning with the EU harmonization legislation enumerated in Annex II.
Addressing the initial criterion, Annex II of the AI Act explicitly encompasses EU Medical Device Regulation 2017/745 (MDR) and EU In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) within the ambit of harmonizing regulations.
Concerning the latter criterion, under the MDR, all devices categorized as risk class IIa or higher undergo third-party conformity assessment (by a notified body) prior to market entry.
For medical device software, reference is made to classification rule no. 11 (Annex VIII, Chapter III) of the MDR. This stipulates that software designed to furnish decision-making information for diagnostic or therapeutic purposes typically falls into class IIa, unless exceptional circumstances designate it as class III (if decisions could lead to fatality or irreversible health deterioration) or class IIb (if decisions may result in severe health impairment or necessitate surgery). Software intended for monitoring physiological processes is generally classified as IIa, unless it concerns critical physiological parameters where variation could immediately endanger the patient, in which case it is deemed IIb. Only medical software devices falling outside these specifications are categorized as class I. Consequently, a considerable proportion of medical software items are classified as IIa or higher under the MDR.
Hence, a medical device incorporating or constituting an artificial intelligence system (i.e., software classified as a medical device) would likely fall within the high-risk AI systems category under the AI Act.
Conformity Assessment for High Risk AI Systems
In accordance with a risk-centered strategy, high-risk AI systems are permitted entry into the European market contingent upon fulfilling specific mandatory criteria (such as implementing a management system and upholding transparency obligations towards users) and undergoing a prior conformity assessment.
The existing sectoral legislation already outlines conformity assessment procedures overseen by third-party entities for products like medical devices. The proposed regulation stipulates that an AI system’s compliance with the AI Act must be evaluated as part of the conformity assessment conducted in accordance with sectoral legislation. This serves to streamline procedures for manufacturers, reducing burdens and eliminating potential redundancies.
As a result, assessments of medical devices classified as class IIa or higher will be carried out by the same notified bodies responsible for assessing device safety and performance under the MDR. In such instances, the issuance of the EC certificate of conformity will validate compliance with both the MDR and the AI Act.
AI Act & Medical Devices: Open Points
There are different open points which would require further clarification in order to align the EU MDR and IVDR with the AI Act. For example, the AI Act does not explicitly address clinical investigations and performance studies for medical device and IVD devices containing artificial intelligence. It’s pivotal to emphasize that during this investigational phase, these devices do not mandate a CE marking for the testing process/procedure, nor are they considered as being placed on the market or put into service according to EU product legislation. Currently, the AI Act does not provide any information on the use of these devices in the framework of clinical investigation or performance studies.
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