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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )
In force
- CELEX number:
- 32017R0746
- Form:
- Regulation
- Author:
- European Parliament, Council of the European Union
- Date of document:
- 05/04/2017; Date of signature
- Number of pages:
- 157
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )
In force
- CELEX number:
- 32017R0745
- Form:
- Regulation
- Author:
- European Parliament, Council of the European Union
- Date of document:
- 05/04/2017; Date of signature
- Number of pages:
- 175
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices
COM/2024/43 final
- CELEX number:
- 52024PC0043
- Form:
- Proposal for a regulation
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Date of document:
- 23/01/2024
Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
C/2023/8234
In force
- CELEX number:
- 32023R2713
- Form:
- Implementing regulation
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Date of document:
- 05/12/2023; Date of adoption
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
C/2023/4568
In force
- CELEX number:
- 32023R2197
- Form:
- Delegated regulation
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Date of document:
- 10/07/2023; Date of adoption
P9_TA(2023)0052 Transitional provisions for certain medical devices and in vitro diagnostic medical devices European Parliament legislative resolution of 16 February 2023 on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (COM(2023)0010 — C9-0003/2023 — 2023/0005(COD)) P9_TC1-COD(2023)0005 Position of the European Parliament adopted at first reading on 16 February 2023 with a view to the adoption of Regulation (EU) 2023/… of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
- CELEX number:
- 52023AP0052
- Form:
- Legislative resolution
- Author:
- European Parliament, Committee on Employment and Social Affairs, Committee on the Environment, Public Health and Food Safety, Committee on the Internal Market and Consumer Protection
- Date of document:
- 16/02/2023; Date of vote
- Number of pages:
- 1
Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council (Text with EEA relevance)
C/2023/3948
In force
- CELEX number:
- 32023R1194
- Form:
- Implementing regulation
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Date of document:
- 20/06/2023; Date of adoption
- Number of pages:
- 3
Commission Guidance on the content and structure of the summary of the clinical investigation report (Text with EEA relevance) 2023/C 163/06
C/2023/2622
- CELEX number:
- 52023XC0508(01)
- Form:
- Guideline
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Date of document:
- 08/05/2023; Date of publication
- Number of pages:
- 7
Opinion of the European Economic and Social Committee on ‘Proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) No 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices’ (COM(2023) 10 final — 2023/0005 (COD))
EESC 2023/00203
- CELEX number:
- 52023AE0203
- Form:
- Opinion
- Author:
- European Economic and Social Committee
- Date of document:
- 24/01/2023; Date of vote
- Number of pages:
- 1
Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (Text with EEA relevance)
PE/1/2023/REV/1
In force
- CELEX number:
- 32023R0607
- Form:
- Regulation
- Author:
- European Parliament, Council of the European Union
- Date of document:
- 15/03/2023; Date of signature
- Number of pages:
- 6
Domain: All, Subject matter, 3rd level: Medical devices, Search language: English