Regulatory Pathway

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Rilemo is advancing through a staged regulatory pathway designed to support certification in Europe first, followed by subsequent expansion into the U.S. market. The company is developing its device in alignment with the applicable European MDR (Medical Device Regulation 2017/745) and with the requirements of the relevant U.S. FDA pathway.

Rilemo’s device is classified as Class IIa under the European MDR and is expected to follow a Class II FDA pathway in the United States.

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Current status

Rilemo has already completed in-vitro and ex-vivo validation activities, confirming the core functionality of the technology, and has performed device safety testing in controlled laboratory environments (INFN laboratories).

In parallel, the company has completed the industrialization of the device’s functional components, marking an important transition from technology development toward product readiness. Rilemo is now progressing with a high-fidelity product prototype, which will serve as the basis for the upcoming regulatory testing and evidence-generation activities.

This next product-level configuration will support the execution of the main verification and validation steps required along the certification pathway. These will include the applicable General Safety and Performance Requirements (GSPR) [1] under MDR, as well as key product-level assessments such as electromagnetic compatibility (EMC) and biocompatibility, in accordance with the relevant standards.

Next regulatory steps

Rilemo’s near-term priority is to pursue CE marking first. As outlined in the Roadmap section, the upcoming phase will focus on completing the activities required to move from product readiness to regulatory execution.

Over the coming phase, the company will:

Complete the relevant verification and validation activities on the high-fidelity product configuration.
Initiate clinical activities in autumn 2026, generating clinical evidence to support device evaluation in relevant use settings.
Progress the preparation of the technical documentation required for certification, including design, risk management, clinical evaluation, and manufacturing-related documentation.
Advance toward submission to the Notified Body for the European conformity assessment process.

Further details on completed validation activities and upcoming development milestones are provided in the Clinical Validation section.

Certification strategy

Rilemo is pursuing a Europe-first regulatory strategy, with CE marking representing the first certification milestone and the basis for initial market access across the European Economic Area (EEA). This approach is supported by the company’s European clinical and industrial network, which enables Rilemo to advance validation and certification activities within the ecosystem in which it is currently operating. CE marking enables commercialization across the EEA and may also facilitate access to selected international markets, depending on local regulatory frameworks.

In this context, two markets of particular relevance are the United Kingdom and Switzerland, as mentioned in the Go-to-Market section. In the UK, CE-marked medical devices can currently be placed on the market under transitional provisions established by the MHRA, with Rilemo actively monitoring regulatory developments in the post-Brexit framework [2]. In Switzerland, CE-marked devices classified under the EU MDR can be placed on the market under the EU-Switzerland Mutual Recognition Agreement (MRA) on conformity assessment, subject to Swissmedic oversight [3].