Medical device documents in EUDAMED

Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers

31976L0764

EU legislation

Published

7/27/1976

Languages

Commission Regulation (EU) No 112/2011 of 7 February 2011 concerning the classification of certain goods in the Combined Nomenclature

32011R0112

EU legislation

Published

2/7/2011

Languages

Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)

32005L0050

EU legislation

Published

8/11/2005

Languages

Commission Implementing Decision (EU) 2026/760 of 1 April 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilizers for medical purposes – small steam sterilizers, stainless steel steam boilers and electroacoustics – hearing aids

32026D0760

EU legislation

Published

4/1/2026

Languages

Commission Delegated Directive 2014/1/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 as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation Text with EEA relevance

32014L0001

EU legislation

Published

10/18/2013

Languages

Commission Implementing Decision (EU) 2020/452 of 26 March 2020 amending Implementing Decision (EU) 2019/570 as regards capacities established to respond to low probability risks with a high impact (notified under document C(2020) 2011) (Text with EEA relevance)

32020D0452

EU legislation

Published

3/26/2020

Languages

Commission Implementing Regulation (EU) 2022/556 of 1 April 2022 concerning the classification of certain goods in the Combined Nomenclature

32022R0556

EU legislation

Published

4/1/2022

Languages

Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance)

32022R0123

EU legislation

Published

1/25/2022

Languages

Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices (Text with EEA relevance)

32022R0112

EU legislation

Published

1/25/2022

Languages

Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects

32021D0611

EU legislation

Published

4/14/2021

Languages

Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

32021R2282

EU legislation

Published

12/15/2021

Languages

Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC

32020D0438

EU legislation

Published

3/24/2020

Languages

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

31993L0042

EU legislation

Published

6/14/1993

Languages

Commission Delegated Directive (EU) 2021/1979 of 11 August 2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic resonance imaging (MRI) detector coils (Text with EEA relevance)

32021L1979

EU legislation

Published

8/11/2021

Languages

Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices

32024R2699

EU legislation

Published

10/18/2024

Languages

Commission Delegated Directive (EU) 2016/585 of 12 February 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices or electron microscopes (Text with EEA relevance)

32016L0585

EU legislation

Published

2/12/2016

Languages

Council Directive 84/539/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine

31984L0539

EU legislation

Published

9/17/1984

Languages

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

32021D1182

EU legislation

Published

7/16/2021

Languages

Commission Regulation (EEC) No 3524/88 of 11 November 1988 amending Article 13 and Annex I in Regulation (EEC) No 1751/84 laying down certain provisions for the application of Council Regulation (EEC) No 3599/82 on temporary importation arrangements

31988R3524

EU legislation

Published

11/11/1988

Languages

Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU (Text with EEA relevance)

32010L0032

EU legislation

Published

5/10/2010

Languages

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