EU Commission publishes titles and references of harmonised standards under Union harmonisation legislation.

November 17th the Official Journal of the European Union, C389 published the titles and references of harmonised standards under Union harmonisation for each of the medical device directives:

  • 2017/C 389/02: list of harmonised standards for Directive 90/385/EEC relating to active implantable medical devices (AIMDD);
  • 2017/C 389/03: list of harmonised standards for Directive 93/42/EEC relating to medical devices (MDD);
  • 2017/C 389/04: list of harmonised standards for Directive 98/79/EC relating to in vitro diagnostics medical devices (IVDD).

Two key changes applicable to all three directives are:

  • Official withdrawal of the standard regarding symbols for use in the labelling of medical devices EN 980:2008 which is now replaced by EN ISO 15223-1:2016;
  • Harmonisation of ISO 13485 :2016 regarding Quality management systems – Requirements for regulatory purposes.
Table 1: Changes versus 2016 list of Harmonised standards relating to in vitro diagnostics medical devices (IVDD):

Name of the standard

Action

Date of cessation of presumption of conformity of superseded standard

EN 980:2008 – Symbols for use in the labelling of medical devices

Officially withdrawn

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)

New publication

EN ISO 13485:2016– Medical Devices – Quality management systems – Requirements for regulatory purposes
EN ISO 13485 :2016/AC :2016

Replaces EN ISO 13485:2012

31.03.2019

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)

New publication, replaces EN 980:2008

31.12.2017

Table 2: Changes versus 2016 list of Harmonised standards relating to medical devices (MDD):

Name of the standard

Action

Date of cessation of presumption of conformity of superseded standard

EN 980:2008 – Symbols for use in the labelling of medical devices

Officially withdrawn

EN ISO 13485:2016– Medical Devices – Quality management systems – Requirements for regulatory purposes
EN ISO 13485 :2016/AC :2016

Replaces EN ISO 13485:2012

31.3.2019

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)

New publication, replaces EN 980:2008

31.12.2017

EN 60601-1-3:2008/A11:2016 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-3:2008

New publication, replaces EN 60601-1-3:2008

1.11.2019

EN 60601-1-8:2007/A11:2017 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-8:2006

New publication, replaces EN 60601-1-8:2007

7.1.2020

EN 60601-2-33:2010 Medical electrical equipment – Part 2-33: Requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601
IEC 60601-2-33:2010

New publication, replaces EN 60601-2-33:2002
+ A1:2005
+ A2:2008

31.12.2017

EN 60601-2-33:2010/A1:2015
IEC 60601-2-33:2010/A1:2013

New publication

14.04.2018

EN 60601-2-33:2010/A2:2015
IEC 60601-2-33:2010/A2:2015

New publication

23.07.2018

EN 60601-2-33:2010/AC:2016-03

New publication

EN 60601-2-33:2010/A12:2016

New publication

01.112019

EN ISO 10328:2016 Prosthetics – Structural testing of lower-limb prostheses Requirements and test methods

New publication, replaces EN ISO 10328:2006

30.6.2018

EN ISO 14155:2011/AC:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011)

New Publication in addition to existing EN ISO 14155:2011

EN ISO 22675:2016 Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2016)

New publication, replaces EN ISO 22675:2006

30.6.2018

Table 3: Changes versus 2016 list of Harmonised standards relating to active implantable medical devices (AIMDD):

Name of the standard

Action

Date of cessation of presumption of conformity of superseded standard

EN 980:2008 – Symbols for use in the labelling of medical devices

Officially withdrawn

EN ISO 13485:2016– Medical Devices – Quality management systems – Requirements for regulatory purposes
EN ISO 13485 :2016/AC :2016

Replaces EN ISO 13485:2012

31.3.2019

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)

New publication, replaces EN 980:2008

31.12.2017

EN ISO 14155:2011/AC:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011)

New Publication in addition to existing EN ISO 14155:2011

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