CELEX: 
Language: en
Date: 2020-03-24 00:00:00
Title: COMMISSION IMPLEMENTING DECISION (EU) …/… on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC

EUROPEAN
                          COMMISSION
                                                   Brussels, 24.3.2020
                                                   C(2020) 1902 final
               COMMISSION IMPLEMENTING DECISION (EU) …/…
                                       of 24.3.2020
   on the harmonised standards for active implantable medical devices drafted in support
                            of Council Directive 90/385/EEC
EN                                                                                       EN
 ---pagebreak---                       COMMISSION IMPLEMENTING DECISION (EU) …/…
                                                   of 24.3.2020
     on the harmonised standards for active implantable medical devices drafted in support
                                       of Council Directive 90/385/EEC
   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 Council1, and in particular Article 10(6)
   thereof,
   Whereas:
   (1)     In accordance with Article 5(1) of Council Directive 90/385/EEC2 Member States are
           to presume compliance with the essential requirements referred to in Article 3 of that
           Directive in respect of active implantable medical devices which are in conformity
           with the relevant national standards adopted pursuant to the harmonised standards the
           references of which have been published in the Official Journal of the European
           Union.
   (2)     By letters BC/CEN/CENELEC/09/89 of 19 December 1991 and M/295 of 9
           September 1999, the Commission made requests to the European Committee for
           Standardisation (CEN) and the European Committee for Electrotechnical
           Standardisation (Cenelec) for the drafting of new harmonised standards and the
           revision of existing harmonised standards in support of Directive 90/385/EEC.
   (3)     On the basis of the request M/295 of 9 September 1999, CEN revised the harmonised
           standard EN ISO 10993-11:2009, the reference of which has been published in the
           Official Journal of the European Union3, in order to include the latest technical and
           scientific progress. This resulted in the adoption of the harmonised standard EN ISO
           10993-11:2018.
   (4)     The Commission together with CEN has assessed whether the harmonised standard
           EN ISO 10993-11:2018 complies with the request.
   (5)     The harmonised standard EN ISO 10993-11:2018 satisfies the requirements which it
           aims to cover and which are set out in Directive 90/385/EEC. It is therefore
           appropriate to publish the reference of that standard in the Official Journal of the
           European Union.
   1
           OJ L 316, 14.11.2012, p. 12.
   2
           Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States
           relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
   3
           OJ C 389, 17.11.2017, p. 22.
EN                                                         1                                                  EN
 ---pagebreak---    (6)  The harmonised standard EN ISO 10993-11:2018 replaces the harmonised standard
        EN ISO 10993-11:2009. It is therefore necessary to withdraw the reference of standard
        EN ISO 10993-11:2009 from the Official Journal of the European Union. In order to
        give manufacturers sufficient time to adapt their products to the revised specifications
        in standard EN ISO 10993-11:2018, it is necessary to defer the withdrawal of the
        reference of standard EN ISO 10993-11:2009.
   (7)  On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN
        revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and
        EN ISO 13485:2016, the references of which have been published in the Official
        Journal of the European Union4, in order to include the latest technical and scientific
        progress. This resulted in the adoption of the harmonised standards EN ISO 11137-
        1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO
        13485:2016/AC:2018.
   (8)  The Commission together with CEN has assessed whether the harmonised standards
        EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN
        ISO 13485:2016/AC:2018 comply with the request.
   (9)  The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018
        and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which
        they aim to cover and which are set out in Directive 90/385/EEC. It is therefore
        appropriate to publish the references of those standards and of the corrigendum in the
        Official Journal of the European Union.
   (10) The harmonised standards EN ISO 11137-1:2015/A2:2019, EN ISO 13408-2:2018 and
        the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standards EN
        ISO 11137-1:2015 and EN ISO 13408-2:2011 and the corrigendum EN ISO
        13485:2016/AC:2016 respectively. It is therefore necessary to withdraw the references
        of the harmonised standard EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and of
        corrigendum EN ISO 13485:2016/AC:2016 from the Official Journal of the European
        Union. In order to give manufacturers sufficient time to adapt their products to the
        revised specifications in the harmonised standards EN ISO 11137-1:2015/A2:2019
        and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018, it is
        necessary to defer the withdrawal of the references of harmonised standards EN ISO
        11137-1:2015 and EN ISO 13408-2:2011 and of corrigendum EN ISO
        13485:2016/AC:2016.
   (11) On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN
        drafted the new harmonised standard EN ISO 25424:2019. The Commission together
        with CEN has assessed whether that standard complies with the request.
   (12) The harmonised standard EN ISO 25424:2019 satisfies the requirements which it aims
        to cover and which are set out in Directive 90/385/EEC. It is therefore appropriate to
        publish the reference of that standard in the Official Journal of the European Union.
   (13) In the interests of clarity and legal certainty, a complete list of references of
        harmonised standards drafted in support of Directive 90/385/EEC and satisfying the
        essential requirements they aim to cover should be published in one act. The other
        references of standards published in the Commission communication 2017/C 389/025
   4
        OJ C 389, 17.11.2017, p. 22.
   5
        Commission communication in the framework of the implementation of Council Directive 90/385/EEC
        on the approximation of the laws of the Member States relating to active implantable medical devices
        (2017/C 389/02) (OJ C 389, 17.11.2017, p. 22).
EN                                                   2                                                       EN
 ---pagebreak---            should therefore also be included in this Decision. That Communication should
           therefore be repealed from the date of entry into force of this Decision. However, it
           should continue to apply in respect of the references of the harmonised standards that
           are withdrawn by this Decision, given that it is necessary to defer withdrawal of those
           references.
   (14)    In accordance with the second subparagraph of Article 120(2) of Regulation (EU)
           2017/745 of the European Parliament and of the Council6, certificates issued by
           notified bodies in accordance with Directive 90/385/EEC from 25 May 2017 are to
           remain valid until the end of the period indicated on the certificate, which is not to
           exceed five years from its issuance. They are, however, to become void at the latest on
           27 May 2024. In accordance with the first subparagraph of Article 120(3) of
           Regulation (EU) 2017/745 a device which has a certificate that was issued in
           accordance with Directive 90/385/EEC and that is valid by virtue of Article 120(2) of
           Regulation (EU) 2017/745, may be placed on the market or put into service until 26
           May 2024, provided that from 26 May 2020 it continues to comply with Directive
           90/385/EEC, and provided there are no significant changes in the design and intended
           purpose. This Decision should therefore apply only until 26 May 2024.
   (15)    The requirements for implantable medical devices laid down in Directive 90/385/EEC
           are different from those laid down in Regulation (EU) 2017/745. The standards drafted
           in support of Directive 90/385/EEC should therefore not be used to demonstrate
           conformity with the requirements of Regulation (EU) 2017/745.
   (16)    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 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.
   6
           Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
           devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
           1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
EN                                                      3                                                    EN
 ---pagebreak---                                               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.
   Done at Brussels, 24.3.2020
                                                For the Commission
                                                The President
                                                Ursula VON DER LEYEN
EN                                                4                                                  EN
 ---documentbreak---                           EUROPEAN
                          COMMISSION
                                                  Brussels, 24.3.2020
                                                  C(2020) 1902 final
                                                  ANNEXES 1 to 2
                                        ANNEXES
                                           to the
                  Commission Implementing Decision (EU) .../... of XXX
   on the harmonised standards for active implantable medical devices drafted in support
                            of Council Directive 90/385/EEC
EN                                                                                       EN
 ---pagebreak---                                           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)
EN                                            1                                                    EN
 ---pagebreak---    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)
   14. EN ISO 10993-16:2010
       Biological evaluation of medical devices - Part 16: Toxicokinetic study design for
       degradation products and leachables (ISO 10993-16:2010)
   15. EN ISO 10993-17:2009
       Biological evaluation of medical devices - Part 17: Establishment of allowable limits
       for leachable substances (ISO 10993-17:2002)
   16. EN ISO 10993-18:2009
       Biological evaluation of medical devices - Part 18: Chemical characterization of
       materials (ISO 10993-18:2005)
   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)
   23. EN ISO 11607-1:2009
       Packaging for terminally sterilized medical devices - Part 1: Requirements for
       materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
EN                                              2                                                 EN
 ---pagebreak---    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
   25. EN ISO 11737-2:2009
       Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility
       performed in the definition, validation and maintenance of a sterilization process (ISO
       11737-2:2009)
   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
   34. EN ISO 14155:2011
       Clinical investigation of medical devices for human subjects - Good clinical practice
       (ISO 14155:2011)
       EN ISO 14155:2011/AC:2011
   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)
EN                                             3                                                EN
 ---pagebreak---    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)
EN                                              4                                              EN
 ---pagebreak---    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.
EN                                            5                                              EN
 ---pagebreak---                                           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
EN                                              6                                           EN