Document ID: 02020D0439-20210415
Language: ENG

02020D0439 — EN — 15.04.2021 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING DECISION (EU) 2020/439</p><p>of 24 March 2020</p><p><a>on the harmonised standards for<span>in vitro</span> diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council</a></p><p>(OJ L 090I 25.3.2020, p. 33)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING DECISION (EU) 2021/609&#160;of 14&#160;April 2021</a></p></td><td><p>&#160;&#160;L&#160;129</p></td><td><p>150</p></td><td><p>15.4.2021</p></td></tr></table>
COMMISSION IMPLEMENTING DECISION (EU) 2020/439
of 24 March 2020
on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council
Article 1
The references of the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC and listed in Annex I to this Decision are hereby published in the Official Journal of the European Union .
Article 2
Commission communication 2017/C 389/04 is repealed. It shall continue to apply until 30 September 2021 in respect of the references of the harmonised standards listed in Annex II to this Decision.
Article 3
The harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/746.
Article 4
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
It shall apply until 26 May 2024.
ANNEX I
<table><col/><col/><tbody><tr><td><p>No</p></td><td><p>Reference of the standard</p></td></tr><tr><td><p>1.</p></td><td><p>EN 556-1:2001</p><p>Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices</p><p>EN 556-1:2001/AC:2006</p></td></tr><tr><td><p>2.</p></td><td><p>EN 556-2:2015</p><p>Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices</p></td></tr><tr><td><p>3.</p></td><td><p>EN ISO 11137-1:2015</p><p>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)</p><p>EN ISO 11137-1:2015/A2:2019</p></td></tr><tr><td><p>4.</p></td><td><p>EN ISO 11137-2:2015</p><p>Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)</p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p>5.</p></td><td><p>EN ISO 11737-2:2020</p><p>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)</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr><tr><td><p>6.</p></td><td><p>EN 12322:1999</p><p>In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media</p><p>EN 12322:1999/A1:2001</p></td></tr><tr><td><p>7.</p></td><td><p>EN ISO 13408-1:2015</p><p>Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)</p></td></tr><tr><td><p>8.</p></td><td><p>EN ISO 13408-2:2018</p><p>Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)</p></td></tr><tr><td><p>9.</p></td><td><p>EN ISO 13408-3:2011</p><p>Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)</p></td></tr><tr><td><p>10.</p></td><td><p>EN ISO 13408-4:2011</p><p>Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)</p></td></tr><tr><td><p>11.</p></td><td><p>EN ISO 13408-5:2011</p><p>Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)</p></td></tr><tr><td><p>12.</p></td><td><p>EN ISO 13408-6:2011</p><p>Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)</p></td></tr><tr><td><p>13.</p></td><td><p>EN ISO 13408-7:2015</p><p>Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)</p></td></tr><tr><td><p>14.</p></td><td><p>EN ISO 13485:2016</p><p>Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)</p><p>EN ISO 13485:2016/AC:2018</p></td></tr><tr><td><p>15.</p></td><td><p>EN 13532:2002</p><p>General requirements for in vitro diagnostic medical devices for self-testing</p></td></tr><tr><td><p>16.</p></td><td><p>EN 13612:2002</p><p>Performance evaluation of in vitro diagnostic medical devices</p><p>EN 13612:2002/AC:2002</p></td></tr><tr><td><p>17.</p></td><td><p>EN 13641:2002</p><p>Elimination or reduction of risk of infection related to in vitro diagnostic reagents</p></td></tr><tr><td><p>18.</p></td><td><p>EN 13975:2003</p><p>Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects</p></td></tr><tr><td><p>19.</p></td><td><p>EN 14136:2004</p><p>Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures</p></td></tr><tr><td><p>20.</p></td><td><p>EN 14254:2004</p><p>In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans</p></td></tr><tr><td><p>21.</p></td><td><p>EN 14820:2004</p><p>Single-use containers for human venous blood specimen collection</p></td></tr><tr><td><p>22.</p></td><td><p>EN ISO 14937:2009</p><p>Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)</p></td></tr><tr><td><p>23.</p></td><td><p>EN ISO 14971:2012</p><p>Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)</p></td></tr><tr><td><p>24.</p></td><td><p>EN ISO 15193:2009</p><p>In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)</p></td></tr><tr><td><p>25.</p></td><td><p>EN ISO 15194:2009</p><p>In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)</p></td></tr><tr><td><p>26.</p></td><td><p>EN ISO 15197:2015</p><p>In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)</p></td></tr><tr><td><p>27.</p></td><td><p>EN ISO 15223-1:2016</p><p>Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)</p></td></tr><tr><td><p>28.</p></td><td><p>EN ISO 17511:2003</p><p>In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)</p></td></tr><tr><td><p>29.</p></td><td><p>EN ISO 18113-1:2011</p><p>In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)</p></td></tr><tr><td><p>30.</p></td><td><p>EN ISO 18113-2:2011</p><p>In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)</p></td></tr><tr><td><p>31.</p></td><td><p>EN ISO 18113-3:2011</p><p>In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)</p></td></tr><tr><td><p>32.</p></td><td><p>EN ISO 18113-4:2011</p><p>In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)</p></td></tr><tr><td><p>33.</p></td><td><p>EN ISO 18113-5:2011</p><p>In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)</p></td></tr><tr><td><p>34.</p></td><td><p>EN ISO 18153:2003</p><p>In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)</p></td></tr><tr><td><p>35.</p></td><td><p>EN ISO 20776-1:2006</p><p>Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)</p></td></tr><tr><td><p>36.</p></td><td><p>EN ISO 23640:2015</p><p>In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)</p></td></tr><tr><td><p>37.</p></td><td><p>EN ISO 25424:2019</p><p>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)</p></td></tr><tr><td><p>38.</p></td><td><p>EN 61010-2-101:2002</p><p>Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment</p></td></tr><tr><td><p>39.</p></td><td><p>EN 61326-2-6:2006</p><p>Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment</p></td></tr><tr><td><p>40.</p></td><td><p>EN 62304:2006</p><p>Medical device software - Software life-cycle processes (IEC 62304:2006)</p><p>EN 62304:2006/AC:2008</p></td></tr><tr><td><p>41.</p></td><td><p>EN 62366:2008</p><p>Medical devices - Application of usability engineering to medical devices</p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p>42.</p></td><td><p>EN ISO 11607-1:2020</p><p>Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)</p></td></tr><tr><td><p>43.</p></td><td><p>EN ISO 11607-2:2020</p><p>Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr></tbody></table>
ANNEX II
<table><col/><col/><tbody><tr><td><p>No</p></td><td><p>Reference of the standard</p></td></tr><tr><td><p>1.</p></td><td><p>EN ISO 11137-1:2015</p><p>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)</p></td></tr><tr><td><p>2.</p></td><td><p>EN ISO 13408-2:2011</p><p>Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)</p></td></tr><tr><td><p>3.</p></td><td><p>EN ISO 13485:2016</p><p>Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)</p><p>EN ISO 13485:2016/AC:2016</p></td></tr></tbody></table>