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HARMONIZED STANDARDS

Lists of harmonized standards published in the Official Journal — [reference and title of the act]
The lists below consolidate the references of harmonized standards published by the Commission in the Official Journal of the European Union (OJ) and reproduce information already published in the L or C series of the OJ, as shown in columns (2), (5) and/or (7). All references contained therein, at the time of elaboration of these lists, continued to confer a presumption of conformity together with references already withdrawn from the OJ.
The European Commission services provide these lists for information purposes only. While they take all possible precautions to ensure that these lists are regularly updated and correct, errors may still occur, which means that the lists may be incomplete at some point. The lists do not generate legal effects as such.

Date: 09.10.2024

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Reference information on legislation and standards
(A) Reference number of a relevant directive/regulation under which it was published in the OJ
(B) The European standardisation organisation who adopted the relevant standard
(C) Reference number of a relevant European standard or of a European standard and its amendment(s)
(D) Title of a European standard

Dates and OJ references for establishing a presumption of conformity
(1) The date on which the presumption of conformity begins or began in cases where a reference has been published in the OJ without restriction. This date is usually, but not always, the same as the OJ reference date in column (2)
(2) The reference number and date of a relevant publication in the L or C series of the OJ in cases where a reference has been published without restriction in the OJ

Dates and OJ references for establishing a presumption of conformity with restrictions
(3) Restriction published in the OJ to limit the presumption of conformity — this includes restrictions made on formal objections
(4) Date on which the presumption of conformity begins or began in cases where a reference has been published with restrictions in the OJ. This date is usually, but not always, the same as the date in column (5)
(5) Reference number and date of a relevant publication in the L or C series of the OJ in cases where a reference has been published with restrictions in the OJ

Dates and OJ references for establishing a presumption of conformity
(6) Date on which a presumption of conformity ends or has ended
(7) Reference number and date of a relevant publication in the L or C series of the OJ when the date of withdrawal from the OJ was published [date in column (6)]

List of MDR harmonized standards
download document …

List of IVDR harmonized standards
download document …

The lists are also posted on the European Commission website:
MDR
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
IVDR
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en