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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)

EU-V: U32 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

Gruppe: Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzung am 14.01.2026

Erstellt am 17.12.2025 von: Generalsekretariat des Rates

Eingelangt am 18.12.2025, CIxP Übermittlung

Dokumentennummern, Nummern von veröffentlichten Rechtsakten sowie Hinweise auf das Amtsblatt der EU, auf die im Text des Dokuments Bezug genommen wird, werden hier aufgelistet und führen zu den entsprechenden Texten der EU. Wir können nicht garantieren, dass die extern verlinkten Inhalte immer vorhanden bzw. korrekt sind.
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Linkart Link
COM
Kommission
COM(2019)196
COM
Kommission
COM(2024)560
COM
Kommission
COM(2025) 1023
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
INT
Interinstitutionelle Zahl
2025/0223 (COD)
INT
Interinstitutionelle Zahl
2025/0404 (COD)
RAT
Rat
15380/24
RMA
Ratsmateriencodes
A 62
RMA
Ratsmateriencodes
CODEC 2154
RMA
Ratsmateriencodes
COMPET 1367
RMA
Ratsmateriencodes
MI 1071
RMA
Ratsmateriencodes
PHARM 194
RMA
Ratsmateriencodes
SAN 850
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 151, 7.6.2019
ABL
Amtsblatter
OJ L 158, 27.5.2014
ABL
Amtsblatter
OJ L 158, 27.5.2014, p. 1
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
2010/53/EU
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
Dokumente mit derselben Dokumentennummer als Basiszahl. Zusatzdokumente zur Änderung des Ausgangsdokuments werden hinzugefügt (COR, REV, ADD)
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Datum EU-Datenbanknr. Dokument der EU-Vorlage Sprache Einstufung
17.12.2025 51571/EU XXVIII.GP
englisch PUBLIC

EU-Vorlage: Offizielles Ratsdokument

Annexes to the 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

Eingelangt am 18.12.2025, CIxP Übermittlung
17.12.2025 51574/EU XXVIII.GP
englisch PUBLIC

EU-Vorlage: Offizielles Ratsdokument

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

Eingelangt am 18.12.2025, CIxP Übermittlung
17.12.2025 51575/EU XXVIII.GP
englisch PUBLIC

EU-Vorlage: Offizielles Ratsdokument

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

Eingelangt am 18.12.2025, CIxP Übermittlung
17.12.2025 51577/EU XXVIII.GP
englisch PUBLIC

EU-Vorlage: Offizielles Ratsdokument

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

Eingelangt am 18.12.2025, CIxP Übermittlung
Legislativvorschläge und sonstige Mitteilungen der Kommission an den Rat und/oder andere Organe sowie vorbereitende Dokumente
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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) 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)
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)
Gesetzgebungsvorhaben der Kommission erhalten eine fortlaufende Nummer mit Jahresangabe und Kürzel des Verfahrens (z.B.: COD, NLE). Diese Zahl wird von den beteiligten EU-Institutionen über sämtliche Etappen eines Verfahrens bis zur Annahme verwendet. Dies ermöglicht die Zusammenstellung vollständiger Dossiers
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Interinstitutionelle Zahl
Der Link führt zu den einzelnen Dokumenten dieses Vorhabens.
Link
2025/0404 COD Legislative Observatory
Zusätzliche Dokumente, auf die im Text Bezug genommen oder verwiesen wird (Vordokumente und sonstige Verweise)
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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) 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)
Mit den Sachgebietscodes werden die in einem Dokument behandelten Themenbereiche des Rates ausgewiesen. Der Link führt zu Dokumenten mit dem gleichen Sachgebiet
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Dieser Link führt zum Filter für die Dokumentenauswahl nach übergeordneten Themen
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Dok.Nr.
Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.
Links
COM: COM(2025) 1023 EUR-Lex IPEX