Medical Devices Directive (93/42/EEC)

There is a new publications in the OJEU of standards harmonised under the Medical Devices Directive:

17^th November 2017               2017/C 389/03               13 standards added, including

• EN ISO 13485:2016 and EN ISO 13485:2016/AC:2016
  Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
• EN ISO 14155:2011/AC:2011
  Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011)
• 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, Corrected version 2017-03)

Active Implantable Medical Devices Directive (93/42/EEC)

There is a new publications in the OJEU of standards harmonised under the Active Implantable Medical Devices Directive:

17^th November 2017               2017/C 389/02               4 standards added

• EN ISO 13485:2016 and EN ISO 13485:2016/AC:2016
  Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
• EN ISO 14155:2011/AC:2011
  Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011)
• 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, Corrected version 2017-03)

In Vitro Diagnostic Medical Devices Directive (93/42/EEC)

There is a new publications in the OJEU of standards harmonised under the In Vitro Diagnostic Medical Devices Directive:

17^th November 2017               2017/C 389/04               4 standards added

• 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 13485:2016 and EN ISO 13485:2016/AC:2016
  Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
• 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)