The Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices entered into force on May 26th, 2017 and we are now 12 months away from the end of the transition period and the date of application. From May 26th, 2022, all in vitro diagnostic medical devices will need to comply with the new Regulation, meaning manufacturers and stakeholders will have to meet the requirements of the IVDR by this date to place in vitro diagnostic medical devices on the European market.

This newsletter is an introduction to important steps to consider to ensure a successful transition to the new Regulation.

For manufacturers intending to certify their devices under the European in vitro diagnostic medical device regulation, the first step would be to verify that the device is covered by the definitions of a medical device and an in vitro dia­gnostic medical device according to Regulation (EU) 2017/746 Chapter I section 1 article 2 (1) and (2).




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