Medical devices regulations hit the press

Publication in Official Journal sets clock for implementation

Following positive votes in the European Council and Parliament, the Medical Devices Regulation (MDR) - Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices Regulation (IVDR) - Regulation (EU) 2017/746 - were published in the Official Journal of the European Union on 5^th May 2017.

Publication in the Official Journal sets the key dates in the implementation timetable. The Regulations will enter into force on 25^th May 2017 – that is when the Regulations come into effect and the transition period starts. The transition period for the MDR is three years. The transition period of the MDR endson the date of application, that is 25^th May 2020. For the IVDR, the transition period is five years and so the date of application for the IVDR, and the end of its transition period, is 25^th May 2022.

After the date of application, devices with valid MDD, AIMD and IVD certificates can continue to be placed on the market for the period of validity of these certificates - or for up to four years after the date of application for medical devices or two years for IVDs. But many medical devices are Class I, and many IVDs are self-certified, so don’t have certificates and this additional time does not apply. Also, some requirements of Regulations, such as those for post-market surveillance, vigilance reporting and registration, will apply to devices with valid certificates under the Directives from the date of application – remember that is 25^th May 2020 for medical devices and 25^th May 2022 for IVDs.

If you want to make use of this period of validity of certificates under the Directives, it is important that you understand the expiry dates of your existing certificates. Work with your notified body to make sure that your certificates have sufficient validity in your planning to transition products to the Regulations.

The time for prevarication is over. The timelines are set. You need to start implementing your transition plans. Failing to be ready in time could stop you selling your devices in the EU. BSI’s free white papers and Compliance Navigator can help you. 

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.