Implantable devices and class III devices: Delegated Regulation (EU) 2026/1451

With the publication of Delegated Regulation (EU) 2026/1451, the European Commission expands the list of implantable devices and class III devices that may benefit from the exemption from the requirement to perform a clinical investigation, provided they are based on Well-Established Technologies (WET).

SCF has prepared a focus piece to delve into a key point that must not be misunderstood: the exemption applies exclusively to the clinical investigation and does not remove the obligation to demonstrate the clinical conformity of the device

Manufacturers must continue to:
🔹 plan and document the clinical evaluation;
🔹 gather sufficient clinical evidence;
🔹 demonstrate safety, performance, and a favorable benefit-risk ratio in accordance with Regulation (EU) 2017/745.

The Commission’s message is clear: lower administrative burdens where clinical experience is well established, but zero compromises on patient safety.

For many companies, this update represents an opportunity to optimize development time and costs, but it will still require a well-structured regulatory and clinical strategy to demonstrate compliance with MDR requirements.

Ecco la traduzione adatta per chiudere il testo in modo efficace e d’impatto:
The real game-changer isn’t doing less, but proving better when existing clinical evidence is already sufficient!