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)

EU-V: 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

Erstellt am 16.12.2025

Eingelangt am 17.12.2025, Europäische Kommission - Österr. Parlament

COM: SWD(2025) 1051 final
PDF

Linkart	Link
COM Kommission	COM (2025) 45
COM Kommission	COM/2024/206
COM Kommission	COM(2025) 1023
COM Kommission	COM/2025/270
COM Kommission	COM/2025/30
COM Kommission	COM/2025/47
COM Kommission	SWD(2012) 273
COM Kommission	SWD(2025) 1050
COM Kommission	SWD(2025) 1052
RAT Rat	10/30
RAT Rat	12/18
RAT Rat	13/17
RAT Rat	13/32
RAT Rat	14/21
RAT Rat	14/32
RAT Rat	15/32
RAT Rat	17/30
RAT Rat	18/20
RAT Rat	18/30
RMA Ratsmateriencodes	A 342
ABL Amtsblatter	OJ L 117, 5.5.2017
ABL Amtsblatter	OJ L 119, 4.5.2016
ABL Amtsblatter	OJ L 130, 24.4.2020
ABL Amtsblatter	OJ L 158, 27.5.2014
ABL Amtsblatter	OJ L 165, 29.6.2023
ABL Amtsblatter	OJ L 169, 12.7.1993
ABL Amtsblatter	OJ L 189, 20.7.1990
ABL Amtsblatter	OJ L 19, 28.1.2022
ABL Amtsblatter	OJ L 191, 28.7.2023
ABL Amtsblatter	OJ L 20, 31.1.2022
BES Beschlusse	No 768/2008/EC
BES Beschlusse	2017/745
BES Beschlusse	2017/746
BES Beschlusse	2024/1860
BES Beschlusse	2025/2371
RIL Richtlinien	2013/59/Eu
RIL Richtlinien	89/618/Eu
RIL Richtlinien	90/385/EEC
RIL Richtlinien	93/42/EEC
RIL Richtlinien	98/79/EC
VER Verordnungen	2014/282
VER Verordnungen	2014/53
VER Verordnungen	2016/67
VER Verordnungen	2017/2185
VER Verordnungen	2017/74
VER Verordnungen	2020/56
VER Verordnungen	2021/2226
VER Verordnungen	2021/2282
VER Verordnungen	2022/112
VER Verordnungen	2022/123

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: COM(2025) 1023	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)
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) 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: COM(2025) 1023	EUVE EU-Vorlage 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 (51497/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)