Lifecare signs EU Declaration of Conformity for implant electronics
Bergen, Norway, 23 February 2026 – Lifecare ASA (LIFE), a MedTech company developing next-generation implantable Continuous Glucose Monitoring (CGM) technology, today announces that it has signed the EU Declaration of Conformity for the electronics used in its implant system.
The Declaration of Conformity confirms that the electronics module complies with the applicable requirements under relevant European directives, including electromagnetic compatibility (EMC) and radio equipment standards, based on completed compliance testing and finalized technical documentation.
The Declaration has been issued following receipt and review of the final accredited laboratory test reports for electromagnetic compatibility and radio performance. The technical file supporting the Declaration has been completed and archived in accordance with regulatory requirements.
The signed Declaration of Conformity applies to the electronics configuration used in:
- The reproducible implant manufacturing batch.
- The implants currently deployed in the ongoing longevity study (LFC-SEN-002).
- The planned First-in-Human study (pending approval).
- The first commercial veterinary product version.
“This represents the formal legal step required to complete the CE marking process for the electronics module. The Declaration of Conformity confirms that our finalized production-level electronics meet applicable European regulatory requirements,” says Joacim Holter, CEO of Lifecare ASA.
With the Declaration of Conformity now signed, Lifecare will proceed to confirm CE marking status of the veterinary product configuration under applicable EU directives.