Medical device documents in EUDAMED

Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices Text with EEA relevance

32011L0100

EU legislation

Published

12/20/2011

Languages

Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Text with EEA relevance)

32023L1526

EU legislation

Published

5/16/2023

Languages

Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices Text with EEA relevance

32012R0207

EU legislation

Published

3/9/2012

Languages

Commission Implementing Regulation (EU) 2023/2490 of 30 October 2023 concerning the classification of certain goods in the Combined Nomenclature

32023R2490

EU legislation

Published

10/30/2023

Languages

Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices

32025R0117

EU legislation

Published

1/24/2025

Languages

Council Directive 76/117/EEC of 18 December 1975 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres

31976L0117

EU legislation

Published

12/18/1975

Languages

Commission Implementing Decision (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices

32024D0817

EU legislation

Published

3/6/2024

Languages

Commission Regulation (EEC) No 1516/89 of 31 May 1989 amending Regulation (EEC) No 1751/84 laying down certain provisions for the application of Council Regulation (EEC) No 3599/82 on temporary importation arrangements

31989R1516

EU legislation

Published

5/31/1989

Languages

Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices

32022D0729

EU legislation

Published

5/11/2022

Languages

Commission Implementing Regulation (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments

32025R2086

EU legislation

Published

10/17/2025

Languages

Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects

32024D2625

EU legislation

Published

10/8/2024

Languages

Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices

32023R2482

EU legislation

Published

11/13/2023

Languages

Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies (Text with EEA relevance)

32020R0666

EU legislation

Published

5/18/2020

Languages

Commission Implementing Regulation (EU) No 1225/2011 of 28 November 2011 for the purposes of Articles 42 to 52, 57 and 58 of Council Regulation (EC) No 1186/2009 setting up a Community system of reliefs from customs duty (codification)

32011R1225

EU legislation

Published

11/28/2011

Languages

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance)

32007L0047

EU legislation

Published

9/5/2007

Languages

Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices

32023D1410

EU legislation

Published

7/4/2023

Languages

Commission Implementing Regulation (EU) 2017/2243 of 30 November 2017 on repealing Implementing Regulation (EU) No 1212/2014 concerning the classification of certain goods in the Combined Nomenclature

32017R2243

EU legislation

Published

11/30/2017

Languages

Commission Implementing Decision (EU) 2026/197 of 28 January 2026 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of health care products and information supplied by the manufacturer (labelling)

32026D0197

EU legislation

Published

1/28/2026

Languages

Commission Delegated Directive 2014/4/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers Text with EEA relevance

32014L0004

EU legislation

Published

10/18/2013

Languages

Commission Implementing Regulation (EU) No 1212/2014 of 11 November 2014 concerning the classification of certain goods in the Combined Nomenclature

32014R1212

EU legislation

Published

11/11/2014

Languages

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