Draft proposal for a Regulation 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/Technical input from the Commission’s services on the envisaged functioning of regulating Medical Device AI on the basis of the proposal for a revision of MDR/IVDR (90189/EU XXVIII.GP)

RAT: WK 13494/26 LIMITE
06.09.2026
englisch

EU-V: Arbeitsdokument

Draft proposal for a Regulation 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/Technical input from the Commission’s services on the envisaged functioning of regulating Medical Device AI on the basis of the proposal for a revision of MDR/IVDR

Gruppe: Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzungen am 10.09.2026 und 11.09.2026

Erstellt am 06.09.2026

Eingelangt am 07.09.2026, CIxP Übermittlung

RAT: WK 13494/26

Datum	EU-Datenbanknr.	Dokument der EU-Vorlage	Sprache	Einstufung
09.09.2026	90850/EU XXVIII.GP	RAT: WK 13494/26 ADD 1	englisch	LIMITE	Arbeitsdokument Draft proposal for a Regulation 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/Commission presentation on the envisaged functioning of regulating Medical Device AI on the basis of the proposal for a revision of MDR/IVDR Eingelangt am 10.09.2026, CIxP Übermittlung

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
24.08.2026	RAT: CM 3836/26	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 10 and 11 September 2026 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (88734/EU XXVIII.GP)
24.08.2026	RAT: CM 3836/26	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 10 and 11 September 2026 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (88734/EU XXVIII.GP)
27.08.2026	RAT: 12272/26	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 - Exchange of views (89106/EU XXVIII.GP)
27.08.2026	RAT: 12272/26	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 - Exchange of views (89106/EU XXVIII.GP)
30.08.2026	RAT: 12273/26	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 - Exchange of views (89185/EU XXVIII.GP)
30.08.2026	RAT: 12273/26	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 - Exchange of views (89185/EU XXVIII.GP)
01.09.2026	RAT: 12287/26	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 - Exchange of views (89490/EU XXVIII.GP)
01.09.2026	RAT: 12287/26	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 - Exchange of views (89490/EU XXVIII.GP)
02.09.2026	RAT: WK 11070/26	EUWK Arbeitsdokument	Presidency Flash for the meeting of the Working Party on Pharmaceuticals and Medical Devices on 10 and 11 September 2026 (89688/EU XXVIII.GP)
02.09.2026	RAT: WK 11070/26	EUWK Arbeitsdokument	Presidency Flash for the meeting of the Working Party on Pharmaceuticals and Medical Devices on 10 and 11 September 2026 (89688/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
CYBER	Fragen des Cyberraums

Thema
Binnenmarkt und Wettbewerb
Forschung und Innovation
Gesundheitswesen
Informationsgesellschaft, Audiovisuelle Politik und Medienpolitik
Institutionelle Fragen
Verbraucher- und Lebensmittelsicherheit

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
24.08.2026	RAT: CM 3836/26	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 10 and 11 September 2026 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (88734/EU XXVIII.GP)