Presentation by the Commission on the Regulation to simplify rules on medical and in vitro diagnostic devices (53396/EU XXVIII.GP)

EU-V: Arbeitsdokument

Presentation by the Commission on the Regulation to simplify rules on medical and in vitro diagnostic devices

Gruppe: Ausschuss der Ständigen Vertreter (AStV) - 1. Teil, Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzungen am 14.01.2026 und 23.01.2026

Erstellt am 13.01.2026

Eingelangt am 14.01.2026, CIxP Übermittlung

RAT: WK 345/26

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
08.12.2025	RAT: 16595/25	EUST EU-Vorlage: Offizielles Ratsdokument	ENTWURF EINER ANTWORT AUF EINE ANFRAGE ZUR SCHRIFTLICHEN BEANTWORTUNG E-003111/2025 - Michael von der Schulenburg (NI) "Rechtsgrundlage für EU-Sanktionen und deren Vereinbarkeit mit der Charta der Grundrechte der Europäischen Union" (51150/EU XXVIII.GP)
08.12.2025	RAT: 16597/25	EUST EU-Vorlage: Offizielles Ratsdokument	ENTWURF EINER ANTWORT AUF EINE ANFRAGE ZUR SCHRIFTLICHEN BEANTWORTUNG E-003112/2025 - Michael von der Schulenburg (NI) "Rechtsgrundlage für EU-Sanktionen und deren Vereinbarkeit mit der Charta der Grundrechte der Europäischen Union" (51163/EU XXVIII.GP)
08.12.2025	RAT: 16594/25	EUST EU-Vorlage: Offizielles Ratsdokument	DRAFT REPLY TO QUESTION FOR WRITTEN ANSWER E-002149/2025 - Jean-Paul Garraud (PfE) 'Lifting of economic sanctions against Syria' (49458/EU XXVIII.GP)
08.12.2025	RAT: 16591/25	EUST EU-Vorlage: Offizielles Ratsdokument	DRAFT REPLY TO QUESTION FOR WRITTEN ANSWER E-000984/2025 - João Oliveira (The Left) 'Need for a permanent ceasefire and the escalation of violence in the West Bank' (49417/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)
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)
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)
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 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 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 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 344/26	EUWK Arbeitsdokument	European Biotech Act/Presentation by the Commission (53471/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)
14.01.2026	RAT: 5248/26	EUST EU-Vorlage: Offizielles Ratsdokument	Council Regulation fixing for 2026, 2027 and 2028 the fishing opportunities for certain fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters - Adoption (53737/EU XXVIII.GP)
15.01.2026	RAT: 5288/26	EUST EU-Vorlage: Offizielles Ratsdokument	Attendance of representatives of the EFTA countries at the Working Party on Animals and Veterinary Questions (Chief Veterinary Officers) on 27-28 January 2026 - Approval (53894/EU XXVIII.GP)
15.01.2026	RAT: 5131/26	EUST EU-Vorlage: Offizielles Ratsdokument	Vorschlag für eine VERORDNUNG DES RATES zur Festsetzung der Fangmöglichkeiten für bestimmte Fischbestände und Bestandsgruppen im Mittelmeer und im Schwarzen Meer für 2026 – Annahme (54168/EU XXVIII.GP)
15.01.2026	RAT: 5269/26	EUST EU-Vorlage: Offizielles Ratsdokument	Antworten auf zur schriftlichen Beantwortung eingereichte Anfragen von Mitgliedern des Europäischen Parlaments an den Rat – Prüfung durch den AStV (54188/EU XXVIII.GP)
15.01.2026	RAT: 5243/26	EUST EU-Vorlage: Offizielles Ratsdokument	Attendance of third parties at the Working Party on International Environment Issues (UNECE Aarhus) of 11 February 2026 - Approval (53972/EU XXVIII.GP)
15.01.2026	RAT: CM 1119/26	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Europa-Gebäude, Brüssel 23. Januar 2026 (10:00 Uhr) (54108/EU XXVIII.GP)
19.01.2026	NON: 46/26	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper I, 23 January 2026/Coreper I Flash (54262/EU XXVIII.GP)
20.01.2026	RAT: PE-CONS 63/25	EUPE EU-Vorlage: CO-Entscheidung EP und Rat	VERORDNUNG DES EUROPÄISCHEN PARLAMENTS UND DES RATES zur Einstellung der Einfuhren von russischem Erdgas und zur Vorbereitung der Einstellung von Einfuhren von russischem Öl, zur Verbesserung der Überwachung potenzieller Energieabhängigkeiten und zur Änderung der Verordnung (EU) 2017/1938 (54520/EU XXVIII.GP)
20.01.2026	RAT: 15872/25	EUST EU-Vorlage: Offizielles Ratsdokument	VERORDNUNG zur Festsetzung der Fangmöglichkeiten für bestimmte Fischbestände und Bestandsgruppen im Mittelmeer und im Schwarzen Meer für 2026 (55135/EU XXVIII.GP)
20.01.2026	RAT: 5331/26	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Europa-Gebäude, Brüssel 23. Januar 2026 (10:30 Uhr) (54785/EU XXVIII.GP)
21.01.2026	RAT: WK 838/26	EUWK Arbeitsdokument	Presentation by the Commission on the EU cardiovascular health plan - Safe Hearts Plan (54765/EU XXVIII.GP)
21.01.2026	NON: 59/26	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper I, 23 January 2026/Revised Coreper I Flash (54752/EU XXVIII.GP)
21.01.2026	RAT: WK 552/26	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper (Part 1) on 23 January 2026/Pre-Mertens list of reserves (54842/EU XXVIII.GP)

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

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

Thema
Binnenmarkt und Wettbewerb
Energie
Forschung und Innovation
Gesundheitswesen
Institutionelle Fragen
Verbraucher- und Lebensmittelsicherheit
Wirtschaft, Währung & Finanzen