EU regulations for in vitro diagnostic devices

In Vitro Diagnostic Medical Devices (IVDD, IVDR)

Designation	Title
No. 98/79/EC (current version)	Directive of the European Parliament and of the Council on in vitro diagnostic medical devices // Regulation (EU) No. (EU) 2017/746 partially repeals and replaces Directive 98/79/EC as of May 26, 2022; for exceptions, see Article 112
No. 2008/932/EC	Commission Decision on the application of Article 8 of Directive 98/79/EC of the European Parliament and of the Council
No. 2010/227/EU	Commission Decision on the European Database on Medical Devices (Eudamed)
(EU) 2020/439, as amended by (EU) 2021/609 (hEN April 15, 2021) Repealed	Commission Implementing Decision on harmonized standards for in vitro diagnostic medical devices drawn up in support of Directive 98/79/EC of the European Parliament and of the Council
2017/C/389/4	Commission Communication in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices// This list replaces the previous list published in the Official Journal of the EU

Newly issued EU legislation

Reference	Title
(EU) 2017/746 in PDF format dated January 10, 2026, including amendment (EU) 2024/1860	Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU// partially repeals and replaces Directive 98/79/EC as of May 26, 2022; for exceptions, see Article 112// Amendment (EU) 2024/1860 applies as of July 9, 2024
(EU) 2021/1195 (hEN July 20, 2021) , as amended by: (EU) 2025/679 (hEN April 10, 2025) , (EU) 2024/2625 (hEN October 9, 2024) (EU)2024/817 (hEN March 8, 2024) (EU)2023/1411 (hEN July 5, 2023) (EU)2022/15 (hEN January 7, 2022) (EU)2022/729 (hEN May 12, 2022) List of hENs for the IVDR (as of March 8, 2024, from the EC website, not legally binding)	Commission Implementing Decision on harmonized standards for in vitro diagnostic medical devices drawn up in support of Regulation (EU) 2017/746 of the European Parliament and of the Council, supplemented by the consolidated text of (EU) 2021/1195, including amendment (EU) 2024/2625
No. (EU) 2023/2713	Commission Implementing Regulation designating European Union reference laboratories in the field of in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council
No. (EU) 2022/1107	Commission Implementing Regulation establishing common specifications for certain Class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council (applicable from July 25, 2024)
No. (EU) 2022/945	Commission Implementing Regulation laying down implementing rules for Regulation (EU) 2017/746 of the European Parliament and of the Council as regards fees that may be charged by EU reference laboratories in the field of in vitro diagnostic medical devices
No. (EU)2022/944	Commission Implementing Regulation laying down implementing rules for Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of European Union reference laboratories in the field of in vitro diagnostic medical devices and the criteria for such laboratories
No. (EU) 2017/2185	Commission Implementing Regulation on the list of codes and corresponding device types for the purpose of determining the scope of the designation of notified bodies in the field of medical devices pursuant to Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices pursuant to Regulation (EU) 2017/746
2017/C 126/02	Council Explanatory Memorandum: Council Position (EU) No. 3/2017 at first reading on the adoption of a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
2017/C 126/01	Council Position (EU) No. 3/2017 at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Adopted by the Council on 7 March 2017)