Medical device documents in EUDAMED

Commission Delegated Directive (EU) 2020/366 of 17 December 2019 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 lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (Text with EEA relevance)

32020L0366

EU legislation

Published

12/17/2019

Languages

Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products

32024D2631

EU legislation

Published

10/8/2024

Languages

Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer

32026D1313

EU legislation

Published

6/15/2026

Languages

Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products

32024D0815

EU legislation

Published

3/6/2024

Languages

Commission Delegated Directive (EU) 2022/1631 of 12 May 2022 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 lead in bismuth strontium calcium copper oxide superconductor cables and wires and lead in their electrical connections (Text with EEA relevance)

32022L1631

EU legislation

Published

5/12/2022

Languages

Commission Implementing Decision (EU) 2019/1244 of 1 July 2019 amending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays (notified under document C(2019) 4632) (Text with EEA relevance.)

32019D1244

EU legislation

Published

7/1/2019

Languages

Commission Implementing Regulation (EU) 2026/333 of 5 February 2026 concerning the classification of certain goods in the Combined Nomenclature

32026R0333

EU legislation

Published

2/5/2026

Languages

Commission Delegated Directive (EU) 2021/884 of 8 March 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 the validity period of an exemption for the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems (Text with EEA relevance)

32021L0884

EU legislation

Published

3/8/2021

Languages

Commission Directive (EU) 2019/1834 of 24 October 2019 amending Annexes II and IV to Council Directive 92/29/EEC as regards purely technical adaptations

32019L1834

EU legislation

Published

10/24/2019

Languages

Commission Delegated Directive (EU) 2021/1978 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), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (Text with EEA relevance)

32021L1978

EU legislation

Published

8/11/2021

Languages

Commission Regulation (EU) 2021/2045 of 23 November 2021 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)

32021R2045

EU legislation

Published

11/23/2021

Languages

Commission Implementing Decision (EU) 2025/681 of 8 April 2025 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances

32025D0681

EU legislation

Published

4/8/2025

Languages

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

31998L0079

EU legislation

Published

10/27/1998

Languages

Commission Implementing Regulation (EU) No 1195/2011 of 16 November 2011 concerning the classification of certain goods in the Combined Nomenclature

32011R1195

EU legislation

Published

11/16/2011

Languages

Commission Implementing Regulation (EU) 2024/3122 of 16 December 2024 authorising an exemption pursuant to Regulation (EU) 2024/573 of the European Parliament and of the Council, with regard to the use of fluorinated greenhouse gases with a GWP of 150 or more in blood transport boxes and blood plasma contact shock freezers

32024R3122

EU legislation

Published

12/16/2024

Languages

Commission Delegated Directive 2014/3/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 acetate marker for use in stereotactic head frames for use with CT (Computed Tomography) and MRI and in positioning systems for gamma beam and particle therapy equipment Text with EEA relevance

32014L0003

EU legislation

Published

10/18/2013

Languages

Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC

32020D0437

EU legislation

Published

3/24/2020

Languages

Commission Delegated Directive (EU) 2015/574 of 30 January 2015 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 mercury in intravascular ultrasound imaging systems Text with EEA relevance

32015L0574

EU legislation

Published

1/30/2015

Languages

Commission Implementing Regulation (EU) 2020/2159 of 16 December 2020 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff

32020R2159

EU legislation

Published

12/16/2020

Languages

Commission Regulation (EU) No 847/2012 of 19 September 2012 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards mercury Text with EEA relevance

32012R0847

EU legislation

Published

9/19/2012

Languages

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