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

PŘÍBAŇ ŽOLNERČÍKOVÁ, Veronika. Abstract: Artificial Intelligence Software as a Medical Device according to MDR (Artificial Intelligence Software as a Medical Device according to MDR). In Cyberspace Conference 2022. 2022.

Basic information

• Original name: Abstract: Artificial Intelligence Software as a Medical Device according to MDR
• Authors: PŘÍBAŇ ŽOLNERČÍKOVÁ, Veronika (203 Czech Republic, guarantor, belonging to the institution).
• Edition: Cyberspace Conference 2022, 2022.

Other information

• Original language: English
• Type of outcome: Conference abstract
• Field of Study: 50501 Law
• Country of publisher: Czech Republic
• Confidentiality degree: is not subject to a state or trade secret
• WWW: Program a abstrakty konference Cyberspace ke stažení
• RIV identification code: RIV/00216224:14220/22:00128345
• Organization unit: Faculty of Law
• Keywords (in Czech): umělá inteligence; zdravotnický prostředek; akt o umělé inteligenci; softwarové právo
• Keywords in English: artificial intelligence; medical device; artificial intelligence act; software law
• Tags: rivok
• Tags: International impact, Reviewed

Abstract

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)

Links

• EF16_019/0000822, research and development project: Name: Centrum excelence pro kyberkriminalitu, kyberbezpečnost a ochranu kritických informačních infrastruktur