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)

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