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Date of cessation of presumption of conformity of superseded standard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Officially withdrawn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Date of cessation of presumption of conformity of superseded standard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Officially withdrawn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
