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Category: Medical Devices Directive

Medical Devices Directive

New Harmonised standard list for the In Vitro Diagnostic Medical Devices Directive

Updated on date by author

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:

17th 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)

 

 

Posted in Medical Devices Directive, News |

New Harmonised standard list for the Medical Devices Directive

Updated on date by author

Medical Devices Directive (93/42/EEC)

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

17th 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)

 

 

Posted in Medical Devices Directive, News |

New Harmonised standard list for the Active Implantable Medical Devices Directive

Updated on date by author

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:

17th 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)

 

 

Posted in Medical Devices Directive, News |

MDR (Medical Devices Regulation) to be delayed for one year

Updated on date by author

European Commission has posted the following on the MDR application date:

With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.

This will surely be a relief to many manufacturers currently under pressure to meet the new requirements in light of the COVID-19 crisis.

For more information see below.

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en

Posted in Medical Devices Directive, News |