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Document 49958f4c-ad02-11eb-9767-01aa75ed71a1

Consolidated text: Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC

02020D0438 — EN — 15.04.2021 — 001.001


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COMMISSION IMPLEMENTING DECISION (EU) 2020/438

of 24 March 2020

on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC

(OJ L 090I 25.3.2020, p. 25)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING DECISION (EU) 2021/611 of 14 April 2021

  L 129

158

15.4.2021




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COMMISSION IMPLEMENTING DECISION (EU) 2020/438

of 24 March 2020

on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC



Article 1

The references of the harmonised standards for active implantable medical devices drafted in support of Directive 90/385/EEC 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Commission communication 2017/C 389/02 is repealed.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 active implantable medical devices drafted in support of Directive 90/385/EEC 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) 2017/745.

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 1041:2008

Information supplied by the manufacturer of medical devices

4.

EN ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-1:2009/AC:2010

5.

EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

6.

EN ISO 10993-4:2009

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

7.

EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

8.

EN ISO 10993-6:2009

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

9.

EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-7:2008/AC:2009

10.

EN ISO 10993-9:2009

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

11.

EN ISO 10993-11:2018

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

12.

EN ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

13.

EN ISO 10993-13:2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

▼M1

14.

EN ISO 10993-16:2017

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

▼B

15.

EN ISO 10993-17:2009

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

▼M1

16.

EN ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

▼B

17.

EN ISO 11135-1:2007

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

18.

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

19.

EN ISO 11137-2:2015

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

20.

EN ISO 11138-2:2009

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

21.

EN ISO 11138-3:2009

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

22.

EN ISO 11140-1:2009

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

▼M1

23.

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)

▼B

24.

EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

EN ISO 11737-1:2006/AC:2009

▼M1

25.

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

26.

EN ISO 13408-1:2015

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

27.

EN ISO 13408-2:2018

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

28.

EN ISO 13408-3:2011

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

29.

EN ISO 13408-4:2011

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

30.

EN ISO 13408-5:2011

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

31.

EN ISO 13408-6:2011

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

32.

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)

33.

EN ISO 13485:2016

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

EN ISO 13485:2016/AC:2018

▼M1

34.

EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

▼B

35.

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)

36.

EN ISO 14971:2012

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

37.

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)

38.

EN ISO 17665-1:2006

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

39.

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)

40.

EN 45502-1:1997

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

41.

EN 45502-2-1:2003

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

42.

EN 45502-2-2:2008

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

EN 45502-2-2:2008/AC:2009

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

43.

EN 45502-2-3:2010

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

44.

EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

EN 60601-1:2006/AC:2010

EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)

45.

EN 60601-1-6:2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

46.

EN 62304:2006

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

EN 62304:2006/AC:2008

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

▼M1

47.

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 10993-11:2009

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

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)

3.

EN ISO 13408-2:2011

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

4.

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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