New Medical Devices Regulation now published

The final text of the new European Medical Devices Regulation (MDR) has been published in the Official Journal of the European Union. The Regulation entered into force on May 25th, marking the start of the transition period for manufacturers selling medical devices into Europe.

Are you ready for the changes ahead?

Where can I find further information?

This transition page will be updated regularly with the latest facts. BSI will run a series of webinars and white papers to ensure we share valuable information with you regarding these significant changes.

The official non-BSI websites can also provide additional background and detailed information:

European Commission

Competent authority, MHRA


The final EU Commission text can be found here

Read the final text

If you have questions regarding the changes please contact your BSI Scheme Manager for initial questions.