(EU) 2026/1451 expanding the list of devices exempted from pre-market studies enters into force |

July 19th the (EU) COMMISSION DELEGATED REGULATION 2026/1451 entered into force, extending the list of implantable and class III devices exempted from the obligation to perform pre-market clinical investigations.

Whereas the list of devices exempted from pre-market studies has been extended, the conformity-assessment framework continues to apply, including the need for a clinical evaluation that:

1. justifies use of the exemption,
2. shows sufficient clinical data exist, and the device complies with the applicable common specifications, and
3. is continuously updated through the device lifecycle with post-market clinical follow-up and post-market surveillance data