On 22 September 2026, Helyx Industries signed the agreement with the Notified Body for the conformity assessment of its class C legacy devices pursuant to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), within the deadline of 26 September 2026.
On 22 September 2026, Helyx Industries signed the agreement with the Notified Body for the conformity assessment of its class C legacy devices pursuant to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), within the deadline of 26 September 2026.
Through this step, the Group retains the benefit of the extended transitional period provided for by the Regulation, which allows such devices to be placed on the market until 31 December 2028.
The signing of the agreement is a step along the IVDR regulatory pathway. Over the coming months, the pathway will continue with the preparation of the technical documentation and support for the Notified Body's conformity assessment process.
