Selected Legal Aspects of the Process of Developing and Introducing a New Technology for the Needs of Aesthetic Medicine in the Eu Based on the MDR Regulation

Kodłubański, Łukasz Remigiusz

doi:10.2478/phr-2025-0006

References

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, Recital 2.
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Clinical investigation of medical devices for human subjects - Good clinical practice standard revised ISO 14155:2020 from https://www.iso.org.
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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, recital 64.
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Charter of Fundamental Rights of the European Union (2012/C 326/02), (OJ C 326, 26 October 2012).
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Document 32017R0745R(01), eur-lex.europa.eu; Corrigendum to 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 (OJ L 117, 5.5.2017).
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Document 32017R0745R(03), eur-lex.europa.eu; Sprostowanie do rozporządzenia Parlamentu Europejskiego i Rady (UE) 2017/745 z dnia 5 kwietnia 2017 r. w sprawie wyrobów medycznych, zmiany dyrektywy 2001/83/WE, rozporządzenia (WE) nr 178/2002 i rozporządzenia (WE) nr 1223/2009 oraz uchylenia dyrektyw Rady 90/385/EWG i 93/42/EWG.
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Document 32022R2347, eur-lex.europa.eu; Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council.
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COMMISSION RECOMMENDATION 2003/361/EC OF 6 MAY 2003 CONCERNING THE DEFINITION OF MICRO, SMALL AND MEDIUMSIZED ENTERPRISES (OJ L 124 OF 20 MAY 2003).
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Regulation (EC) No. 765/2008 Official Journal of the EU.L.2008.218.30 of 2008.08.13.
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Regulation 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Journal of Laws UE.L.2017.117.176 of 2017.05.05).
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L.L. Fuller, The Morality of Law, translated by S. Amsterdamski, ABC Publishing House, 2004, p. 53-55.
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J. Zajadło in: Ethics. Law ethics. Lawyer’s ethics., S. Sykuna, E. Szutta, J. Zajadło, Warsaw 2022, p. 63.
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Selected Legal Aspects of the Process of Developing and Introducing a New Technology for the Needs of Aesthetic Medicine in the Eu Based on the MDR Regulation

References

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