Artificial Intelligence Software as a Medical Device according
to MDR

k 2022

Artificial Intelligence Software as a Medical Device according to MDR

PŘÍBAŇ ŽOLNERČÍKOVÁ, Veronika

Basic information

Original name

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

Language

English

Type of outcome

Prezentace na konferencích

Field of Study

50501 Law

Country of publisher

Czech Republic

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Program konference Cyberspace

RIV identification code

RIV/00216224:14220/22:00128346

Organization unit

Faculty of Law

Keywords in English

artificial intelligence; medical device; artificial intelligence act; software law

Abstract

V originále

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

Citovat

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

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   author = {Příbaň Žolnerčíková, Veronika},
   booktitle = {Cyberspace Conference 2022},
   keywords = {artificial intelligence; medical device; artificial intelligence act; software law},
   language = {eng},
   title = {Artificial Intelligence Software as a Medical Device according to MDR},
   url = {https://onedrive.live.com/view.aspx?resid=C78C2138A5553CF4!3525&ithint=file%2cdocx&authkey=!AK9XKr_A-fhImF0},
   year = {2022}
}

TY  - CONF
ID  - 2250459
AU  - Příbaň Žolnerčíková, Veronika
PY  - 2022
TI  - Artificial Intelligence Software as a Medical Device according to MDR
KW  - artificial intelligence
KW  - medical device
KW  - artificial intelligence act
KW  - software law
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N2  - 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)
ER  -

PŘÍBAŇ ŽOLNERČÍKOVÁ, Veronika. Artificial Intelligence Software as a Medical Device according to MDR. In \textit{Cyberspace Conference 2022}. 2022.

Detailed Information on Publication Record