Medical device documents in EUDAMED

Council Directive 83/128/EEC of 28 March 1983 amending Directive 76/764/EEC on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum- reading thermometers

31983L0128

EU legislation

Published

3/28/1983

Languages

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)

32023R0607

EU legislation

Published

3/15/2023

Languages

Commission Implementing Decision (EU) 2026/193 of 28 January 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical devices for human subjects, non-active surgical implants, sterilization of health care products, biocompatibility evaluation of breathing gas pathways in healthcare applications and small-bore connectors for liquids and gases in healthcare applications

32026D0193

EU legislation

Published

1/28/2026

Languages

Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

32022D0015

EU legislation

Published

1/6/2022

Languages

Commission Regulation (EEC) No 3893/88 of 14 December 1988 amending Regulation (EEC) No 2290/83 laying down provisions for the implementation of Articles 50 to 59 of Council Regulation (EEC) No 918/83 setting up a Community system of reliefs from customs duty

31988R3893

EU legislation

Published

12/14/1988

Languages

Commission Implementing Regulation (EU) No 766/2014 of 11 July 2014 concerning the classification of certain goods in the Combined Nomenclature

32014R0766

EU legislation

Published

7/11/2014

Languages

Commission Implementing Decision (EU) 2023/1411 of 4 July 2023 amending Implementing Decision (EU) 2021/1195 as regards a harmonised standard for sterilization of health care products

32023D1411

EU legislation

Published

7/4/2023

Languages

2013/329/EU: Commission Implementing Decision of 26 June 2013 providing the rules for the establishment, management and transparent functioning of the Network of national authorities or bodies responsible for health technology assessment

32013D0329

EU legislation

Published

6/26/2013

Languages

Commission Delegated Directive (EU) 2016/1028 of 19 April 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 in solders of electrical connections to temperature measurement sensors in certain devices (Text with EEA relevance)

32016L1028

EU legislation

Published

4/19/2016

Languages

Commission Regulation (EC) No 1966/2003 of 7 November 2003 amending Regulation (EC) No 834/95 concerning the classification of certain goods in the Combined Nomenclature

32003R1966

EU legislation

Published

11/7/2003

Languages

Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Text with EEA relevance

32013R0920

EU legislation

Published

9/24/2013

Languages

Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups

32024R2745

EU legislation

Published

10/25/2024

Languages

Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation (Text with EEA relevance)

32006R2007

EU legislation

Published

12/22/2006

Languages

Commission Implementing Regulation (EU) 2020/523 of 7 April 2020 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff as regards subheading 90211010 (orthopaedic appliances)

32020R0523

EU legislation

Published

4/7/2020

Languages

Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices

32022D0757

EU legislation

Published

5/11/2022

Languages

Commission Implementing Regulation (EU) No 1213/2014 of 11 November 2014 concerning the classification of certain goods in the Combined Nomenclature

32014R1213

EU legislation

Published

11/11/2014

Languages

Commission Delegated Directive (EU) 2022/1632 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 certain magnetic resonance imaging devices (Text with EEA relevance)

32022L1632

EU legislation

Published

5/12/2022

Languages

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

31990L0385

EU legislation

Published

6/20/1990

Languages

Commission Delegated Directive (EU) 2021/1980 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 ion-selective electrodes for analysing human body fluids and/or dialysate fluids (Text with EEA relevance)

32021L1980

EU legislation

Published

8/11/2021

Languages

Commission Delegated Directive 2014/12/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 in solders on printed circuit boards of detectors and data acquisition units for Positron Emission Tomographs which are integrated into Magnetic Resonance Imaging equipment Text with EEA relevance

32014L0012

EU legislation

Published

10/18/2013

Languages

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