New harmonised standards for medical devices and IVDs


 

 

 



Karen Hill,
Senior Manager, Regulatory Affairs, Medical Device & Diagnostic Research, ICON plc

On 17 November, 2017, the European Commission published updated harmonised standards for medical devices and in vitro diagnostic medical devices in the Official Journal of the European Union.

Harmonised standards are European standards developed by a recognised European Standards Organisation (e.g. CEN, CENELEC) and can be used by medical device manufacturers for supporting declarations of conformity to the Essential Requirements found in Annex I of the EU Medical Devices Directive (MDD 93/42/EEC) or the EU IVD Medical Devices Directive (IVDD 98/79/EC). As standards continually evolve and are updated, so does the list of standards harmonised for each directive.

(Please note that these latest updated lists of harmonised standards do not directly apply to the upcoming European Medical Devices Regulation or In Vitro Diagnostic Medical Devices Regulation). 

The changes to the updated list of harmonised standards for medical devices are as follows:

Reference Title Change
EN980:2008 Symbols for use in the labelling of medical devices Withdrawn
EN ISO 10328:2016 Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods (ISO 10328:2016) Supersedes EN ISO 10328:2006

EN ISO 13485:2016

EN ISO 13485:2016/AC:2016
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) Supersedes EN ISO 13485:2012
EN ISO 14155:2011/AC:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011) First publication of AC:2011
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) First publication; Replaces EN 980:2008

EN ISO 22675:2016

Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2016) Supersedes EN 22675:2006
EN 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests Withdrawn; Replaced by EN 60601-1-2:2015 (harmonised 13 May 2016)
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 First publication of A11:2016
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  First publication of A11:2017

IEC 60601-2-33:2010

EN60601-2-33:2010/A1:2015

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

EN60601-2-33:2010/A2:2015

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

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

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

Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis Supersedes EN 60601-2-33:2002 +A1:2005 + A2:2008

The changes to the list for in vitro diagnostic medical devices are as follows:

Reference Title Change
EN980:2008 Symbols for use in the labelling of medical devices Withdrawn
EN ISO 11137-1:2015 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006, including Amd 1:2013) First Publication

EN ISO 13485:2016

EN ISO 13485:2016/AC:2016

Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) Supersedes EN ISO 13485:2012
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)) First publication; Replaces EN 980:2008

Two key changes that are applicable to both directives and to all medical device manufacturers are:

The harmonisation of EN ISO 13485:2016 on medical device quality management systems.  This updated standard places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements.  The cessation of conformity for EN ISO 13485:2012 is 31 March, 2019, and, therefore, if not already underway, holders of current ISO 13485:2012 certificates should start planning their transition to the 2016 standard.

The withdrawal of EN 980:2008 regarding symbols for use in the labelling of medical devices, which is now replaced by EN ISO 15223-1:2016. The cessation of conformity for EN 980:2008 was 31 December, 2017, and, therefore, all manufacturers should review their medical device labelling and technical documentation to ensure they are compliant with the new 2016 standard.

ICON’s dedicated Medical Device and IVD regulatory and quality experts are available to help you understand these changes and how they impact your products. For assistance with any of the above items, or any aspects of medical device or IVD regulations, please contact us at www.iconplc.com/devices.

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