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    Invitro Regulation Standards

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    This document announces the publication of references to harmonized standards for in vitro diagnostic medical devices. It describes standards developed by the European Committee for Standardization to support Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The Commission has assessed that the standards comply with requirements and it is appropriate to publish their references to presume conformity with essential requirements. This decision enters into force on the date of its publication in the Official Journal of the European Union.

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    Invitro Regulation Standards

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    vesna
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    This document announces the publication of references to harmonized standards for in vitro diagnostic medical devices. It describes standards developed by the European Committee for Standardization to support Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The Commission has assessed that the standards comply with requirements and it is appropriate to publish their references to presume conformity with essential requirements. This decision enters into force on the date of its publication in the Official Journal of the European Union.

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    This document announces the publication of references to harmonized standards for in vitro diagnostic medical devices. It describes standards developed by the European Committee for Standardization to support Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The Commission has assessed that the standards comply with requirements and it is appropriate to publish their references to presume conformity with essential requirements. This decision enters into force on the date of its publication in the Official Journal of the European Union.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    49 views3 pages

    Invitro Regulation Standards

    Uploaded by

    vesna
    This document announces the publication of references to harmonized standards for in vitro diagnostic medical devices. It describes standards developed by the European Committee for Standardization to support Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The Commission has assessed that the standards comply with requirements and it is appropriate to publish their references to presume conformity with essential requirements. This decision enters into force on the date of its publication in the Official Journal of the European Union.

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    © All Rights Reserved
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    of 3

    L 258/50 EN Official Journal of the European Union 20.7.

    2021

    COMMISSION IMPLEMENTING DECISION (EU) 2021/1195


    of 19 July 2021
    on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation
    (EU) 2017/746 of the European Parliament and of the Council

    THE EUROPEAN COMMISSION,

    Having regard to the Treaty on the Functioning of the European Union,

    Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on
    European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
    95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament
    and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European
    Parliament and of the Council (1), and in particular Article 10(6) thereof,

    Whereas:

    (1) In accordance with Article 8 of Regulation (EU) 2017/746 of the European Parliament and of the Council (2), devices
    that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the
    references of which have been published in the Official Journal of the European Union, are to be presumed to be in
    conformity with the requirements of that Regulation covered by those standards or parts thereof.

    (2) By Commission Implementing Decision C(2021) 2406 (3), the Commission made a request to the European
    Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec)
    for the revision of existing harmonised standards on in vitro diagnostic medical devices developed in support of
    Directive 98/79/EC of the European Parliament and of the Council (4) and the drafting of new harmonised
    standards in support of Regulation (EU) 2017/746.

    (3) On the basis of the request set out in Implementing Decision C(2021) 2406, CEN revised the existing harmonised
    standards EN ISO 11135:2014, EN ISO 11137-1:2015, EN ISO 11737-2:2009 and EN ISO 25424:2011, in order
    to include the latest technical and scientific progress, and to adapt them to the relevant requirements of Regulation
    (EU) 2017/746. This resulted in the adoption of the new harmonised standards EN ISO 11737-2:2020 and EN ISO
    25424:2019, and of the amendments EN ISO 11135:2014/A1:2019 to EN ISO 11135:2014 and EN ISO
    11137-1:2015/A2:2019 to EN ISO 11137-1:2015.

    (4) The Commission together with CEN has assessed whether the standards revised and drafted by CEN comply with the
    request set out in Implementing Decision C(2021) 2406.

    (5) The harmonised standards EN ISO 11737-2:2020 and EN ISO 25424:2019 and the amendments EN ISO
    11135:2014/A1:2019 to EN ISO 11135:2014 and EN ISO 11137-1:2015/A2:2019 to EN ISO 11137-1:2015
    satisfy the requirements which they aim to cover and which are set out in Regulation (EU) 2017/746. It is therefore
    appropriate to publish the references of those standards in the Official Journal of the European Union.

    (1) OJ L 316, 14.11.2012, p. 12.


    (2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and
    repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
    (3) Commission Implementing Decision of 14.4.2021 on a standardisation request to the European Committee for Standardization and
    the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of
    the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the
    European Parliament and of the Council.
    (4) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
    (OJ L 331, 7.12.1998, p. 1).
    20.7.2021 EN Official Journal of the European Union L 258/51

    (6) Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential
    requirements set out in Union harmonisation legislation from the date of publication of the reference of such
    standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of
    its publication,

    HAS ADOPTED THIS DECISION:

    Article 1

    The references of harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU)
    2017/746 and listed in the Annex to this Decision are hereby published in the Official Journal of the European Union.

    Article 2

    This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

    Done at Brussels, 19 July 2021.

    For the Commission


    The President
    Ursula VON DER LEYEN
    L 258/52 EN Official Journal of the European Union 20.7.2021

    ANNEX

    No Reference of the standard

    1. EN ISO 11135:2014
    Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and
    routine control of a sterilization process for medical devices (ISO 11135:2014)

    EN ISO 11135:2014/A1:2019
    2. EN ISO 11137-1:2015
    Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine
    control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

    EN ISO 11137-1:2015/A2:2019
    3. EN ISO 11737-2:2020
    Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the
    definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
    4. EN ISO 25424:2019
    Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for
    development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

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