Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51497/EU XXVIII.GP)

EU-V: Verordnungsentwürfe

Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

Erstellt am 16.12.2025

Eingelangt am 17.12.2025, Europäische Kommission - Österr. Parlament

COM: COM(2025) 1023 final
PDF

Linkart	Link
COM Kommission	COM(2019)196
COM Kommission	COM(2024)560
COM Kommission	COM(2025)1022
COM Kommission	COM(2025)30
COM Kommission	COM(2025)47
COM Kommission	COM(2025)525
COM Kommission	C(2020)2297
COM Kommission	C/2022/3689
COM Kommission	C/2025/485
COM Kommission	SWD(2025) 1050
INT Interinstitutionelle Zahl	2025/0223 (COD)
INT Interinstitutionelle Zahl	2025/0404 (COD)
RAT Rat	15380/24
RMA Ratsmateriencodes	A 62
RMA Ratsmateriencodes	AND 26
RMA Ratsmateriencodes	AND 29
ABL Amtsblatter	OJ C 229, 14.6.2022
ABL Amtsblatter	OJ C 229, 14.6.2022, p. 1
ABL Amtsblatter	OJ L 117, 5.5.2017
ABL Amtsblatter	OJ L 117, 5.5.2017, p. 1
ABL Amtsblatter	OJ L 117, 5.5.2017, p. 176
ABL Amtsblatter	OJ L 119, 4.5.2016, p. 1
ABL Amtsblatter	OJ L 124, 20.5.2003, p. 36
ABL Amtsblatter	OJ L 130, 24.4.2020, p. 18
ABL Amtsblatter	OJ L 136, 30.4.2004, p. 1
ABL Amtsblatter	OJ L 151, 7.6.2019
BES Beschlusse	No 1082/2013/EU
BES Beschlusse	No 1247/2002/EC
BES Beschlusse	No 1313/2013/EU
BES Beschlusse	2010/227/EU
BES Beschlusse	2022/2371
BES Beschlusse	2022/2372
EMP Empfehlungen	2003/361/EC
RIL Richtlinien	(EU) 2016/797 and (EU) 2020/1828
RIL Richtlinien	(EU) 2019/882
RIL Richtlinien	(EU) 2020/1828
RIL Richtlinien	(OJ L 117, 5.5.2017, p. 1). 4 Regulation (EU) 2017/746
RIL Richtlinien	(OJ L 117, 5.5.2017, p.1)
RIL Richtlinien	2001/20/EC
RIL Richtlinien	2001/83/EC
RIL Richtlinien	2002/98/EC
RIL Richtlinien	2004/23/EC
RIL Richtlinien	2009/35/EC
RMI Ministerrat des Rates	European Council
VER Verordnungen	1082/2013
VER Verordnungen	1223/2009
VER Verordnungen	1394/2007
VER Verordnungen	167/2013
VER Verordnungen	168/2013
VER Verordnungen	178/2002
VER Verordnungen	2001/20
VER Verordnungen	2001/83
VER Verordnungen	2002/98
VER Verordnungen	2003/361

Interinstitutionelle Zahl Der Link führt zu den einzelnen Dokumenten dieses Vorhabens.	Link
2025/0404 COD	Legislative Observatory

Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Betreff
COM: SWD(2025) 1050	Commission Staff Working Document/Cost-savings accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51498/EU XXVIII.GP)
COM: SWD(2025) 1051	Commission Staff Working Document/Evaluation on the Targeted evaluation of Regulation (EU)2017/745 on Medical Devices and Regulation (EU)2017/746 on In vitro Diagnostic Medical Devices accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51499/EU XXVIII.GP)
COM: SWD(2025) 1052	Commission Staff Working Document/Executive Summary of the Evaluation on the Targeted evaluation of Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In vitro Diagnostic Medical Devices accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51500/EU XXVIII.GP)

Thema
Gesundheitswesen

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
16.12.2025	COM: SWD(2025) 1050	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Commission Staff Working Document/Cost-savings accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51498/EU XXVIII.GP)
16.12.2025	COM: SWD(2025) 1051	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Commission Staff Working Document/Evaluation on the Targeted evaluation of Regulation (EU)2017/745 on Medical Devices and Regulation (EU)2017/746 on In vitro Diagnostic Medical Devices accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51499/EU XXVIII.GP)
16.12.2025	COM: SWD(2025) 1052	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Commission Staff Working Document/Executive Summary of the Evaluation on the Targeted evaluation of Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In vitro Diagnostic Medical Devices accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51500/EU XXVIII.GP)
17.12.2025	RAT: 16919/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51578/EU XXVIII.GP)

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
17.12.2025	RAT: 16919/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51578/EU XXVIII.GP)

Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Links
COM: COM(2025) 1023	EUR-Lex IPEX