Abstract: Artificial Intelligence Software as a Medical Device according to MDR

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Title in English Artificial Intelligence Software as a Medical Device according to MDR


Year of publication 2022
Type Conference abstract
MU Faculty or unit

Faculty of Law

Description Artificial Intelligence Software as a Medical Device according to MDR European Union adopted Medical Devices Regulation (MDR),* which recognizes software as a stand-alone medical device. Whereas previous regulation, the Medical Devices Directive (MDD),** recognized only one circumstance when software is considered to be a medical device, MDR differentiates between several categories of medical device's software, including artificial intelligence. For example, MDR applies to (self-learning) algorithms capable of precise dosage calculation or to smart databases (expert systems). Medical devices are exempted from the application of the proposal for the Artificial Intelligence Act.*** Therefore, the MDR is and will be the only legislative text regulating safeguards, principles and assessment of AI software in healthcare. Unfortunately, the adoption of the new MDR rules in practical context is not easy and in some cases the classification of software according to Annex VIII of MDR raises questions. The talk provides the audience with an overview of the basic MDR principles regarding software and gets the audience familiar with the software classes according to relevant provisions of MDR. Those will be analyzed from a legal standpoint and applied to specific cases of medical devices using artificial intelligence. * Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) ** Council Directive 93/42/EEC of 14 June 1993 concerning medical devices *** Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS (COM/2021/206 final)
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