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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)

EU-V: 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

Gruppe: Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzung am 14.01.2026

Erstellt am 06.01.2026

Eingelangt am 07.01.2026, CIxP Übermittlung

RAT: CM 5535/25
PDF

Linkart	Link
RAT Rat	16919/25
RAT Rat	16945/25
RAG Ratsarbeitsgruppen	Gruppe "Arzneimittel und Medizinprodukte"

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 79/26	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 (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)
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)
11.01.2026	RAT: WK 341/26	EUWK Arbeitsdokument	Flash from the Presidency for the Working Party on Pharmaceuticals and Medical Devices on 14 January 2026 (53136/EU XXVIII.GP)
13.01.2026	RAT: WK 486/26	EUWK Arbeitsdokument	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)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on the Strategic Technologies for Europe Platform (STEP) (Articles) (53369/EU XXVIII.GP)
13.01.2026	RAT: WK 468/26	EUWK Arbeitsdokument	Presentation on the Task Force on the cyber security of medical devices (53460/EU XXVIII.GP)
13.01.2026	RAT: WK 345/26	EUWK Arbeitsdokument	Presentation by the Commission on the Regulation to simplify rules on medical and in vitro daignostic devices (53396/EU XXVIII.GP)
13.01.2026	RAT: WK 480/26	EUWK Arbeitsdokument	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)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on clinical trials on medicinal products for human use (CTR) (Articles) (53363/EU XXVIII.GP)
13.01.2026	RAT: WK 483/26	EUWK Arbeitsdokument	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)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on standards of quality and safety for substances of human origin intended for human application (Articles) (53366/EU XXVIII.GP)
13.01.2026	RAT: WK 482/26	EUWK Arbeitsdokument	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)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on advanced therapy medicinal products (Articles) (53364/EU XXVIII.GP)
13.01.2026	RAT: WK 485/26	EUWK Arbeitsdokument	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)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on General Food Law (Articles) (53370/EU XXVIII.GP)
13.01.2026	RAT: WK 484/26	EUWK Arbeitsdokument	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)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on veterinary medicinal products (Articles) (53367/EU XXVIII.GP)
13.01.2026	RAT: WK 344/26	EUWK Arbeitsdokument	European Biotech Act/Presentation by the Commission (53471/EU XXVIII.GP)

Dok.Nr.

Betreff

RAT: 16919/25

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)

RAT: 16945/25

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)

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
11.01.2026	RAT: WK 341/26	EUWK Arbeitsdokument	Flash from the Presidency for the Working Party on Pharmaceuticals and Medical Devices on 14 January 2026 (53136/EU XXVIII.GP)