Following completion of the conformity assessment process and signing of the EU Declaration of Conformity, the electronics module has formally achieved CE marking under the applicable EMC and Radio Equipment directives, based on completed compliance testing and finalized technical documentation.

As a result, the veterinary product containing these electronics is CE marked under applicable EU product legislation and cleared for commercial sales in Europe.

The CE marked electronics are already in use in the Company’s reproducible production batch and longevity study implants and will be used in the upcoming First-in-Human study.

Electronics used in implantable medical devices are subject to rigorous safety and reliability requirements. Unlike external devices, implant electronics must operate safely inside the body over extended periods without posing electrical, thermal, or electromagnetic risk.

“The CE marking of our electronics represents a significant regulatory milestone,” says Joacim Holter, CEO of Lifecare ASA. “It confirms that the core active component of our implant platform meets stringent European safety and performance requirements in a production-level configuration. This materially strengthens our regulatory foundation ahead of veterinary commercialization and clinical progression. With this milestone achieved, we are now well positioned to establish strategic partnerships for sales and distribution in the veterinary market.”

The CE marking announced today relates specifically to the electronics module under applicable EU directives, namely EMC and Radio Equipment directives, and veterinary commercial use. Lifecare will continue to progress towards regulatory compliance for human use, in line with previously communicated development plans.