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 (IVDR), 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/Consolidated version of proposed amendments to the IVDR Regulation (Articles) (52572/EU XXVIII.GP)

EU-V: Arbeitsdokument

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 (IVDR), 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/Consolidated version of proposed amendments to the IVDR Regulation (Articles)

Gruppe: Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzung am 14.01.2026

Erstellt am 06.01.2026

Eingelangt am 07.01.2026, CIxP Übermittlung

RAT: WK 79/26

Datum	EU-Datenbanknr.	Dokument der EU-Vorlage	Sprache	Einstufung
06.01.2026	52541/EU XXVIII.GP	RAT: WK 79/26 ADD 1	englisch	LIMITE	Arbeitsdokument 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 (IVDR), 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/Consolidated version of proposed amendments to the IVDR Regulation (Annexes) Eingelangt am 07.01.2026, CIxP Übermittlung

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)
21.12.2025	RAT: 16945/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (52034/EU XXVIII.GP)
06.01.2026	RAT: WK 74/26	EUWK Arbeitsdokument	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/Consolidated version of proposed amendments to the MDR Regulation (Articles) (52571/EU XXVIII.GP)
06.01.2026	RAT: CM 5535/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 14 January 2026 Time: 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (52593/EU XXVIII.GP)

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)

Dok.Nr.

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)

Code	Sachgebiet
SAN	Gesundheit
PHARM	Pharmazie
MI	Binnenmarkt
COMPET	Wettbewerbsfähigkeit (Binnenmarkt/Industrie)
CODEC	Mitentscheidungsverfahren