Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose (Annex XVI)

Implementing Regulation (EU) 2022/2346 establishing the Common Specifications (CS) for the groups of products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 has been published. These CS, which are mandatory, provide clarifications regarding requirements for risk management, information to be provided to users, and clinical evaluation.

These CS also introduce transitional provisions to allow devices to remain on the market for which conformity assessment requires a NB.

This regulation enters into force 20 days after its publication in the OJEU.

It shall apply from 22 June 2023. Note that Article 2(3) is applicable from 22 December 2022.

DOWNLOAD THE IMPLEMENTING REGULATION (EU) 2022/2346