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Document 02020D0439-20210415

Consolidated text: 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

ELI: http://data.europa.eu/eli/dec_impl/2020/439/2021-04-15

02020D0439 — EN — 15.04.2021 — 001.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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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

(OJ L 090I 25.3.2020, p. 33)

Amended by:

 

 

Official Journal

  No

page

date

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COMMISSION IMPLEMENTING DECISION (EU) 2021/609 of 14 April 2021

  L 129

150

15.4.2021




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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Commission communication 2017/C 389/04 is repealed.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



No

Reference of the standard

1.

EN 556-1:2001

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

EN 556-1:2001/AC:2006

2.

EN 556-2:2015

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

3.

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

4.

EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

▼M1

5.

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)

▼B

6.

EN 12322:1999

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

EN 12322:1999/A1:2001

7.

EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

8.

EN ISO 13408-2:2018

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

9.

EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

10.

EN ISO 13408-4:2011

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

11.

EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

12.

EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

13.

EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

14.

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/AC:2018

15.

EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

16.

EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002/AC:2002

17.

EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

18.

EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

19.

EN 14136:2004

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

20.

EN 14254:2004

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

21.

EN 14820:2004

Single-use containers for human venous blood specimen collection

22.

EN ISO 14937:2009

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)

23.

EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

24.

EN ISO 15193:2009

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)

25.

EN ISO 15194:2009

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)

26.

EN ISO 15197:2015

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

27.

EN ISO 15223-1:2016

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)

28.

EN ISO 17511:2003

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

29.

EN ISO 18113-1:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

30.

EN ISO 18113-2:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

31.

EN ISO 18113-3:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

32.

EN ISO 18113-4:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

33.

EN ISO 18113-5:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

34.

EN ISO 18153:2003

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)

35.

EN ISO 20776-1:2006

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)

36.

EN ISO 23640:2015

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

37.

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)

38.

EN 61010-2-101:2002

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

39.

EN 61326-2-6:2006

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

40.

EN 62304:2006

Medical device software - Software life-cycle processes (IEC 62304:2006)

EN 62304:2006/AC:2008

41.

EN 62366:2008

Medical devices - Application of usability engineering to medical devices

▼M1

42.

EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

43.

EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

▼B




ANNEX II



No

Reference of the standard

1.

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)

2.

EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

3.

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/AC:2016

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