RESIL.IO Health has officially obtained CE marking as a Class I medical device under EU MDR 2017/745, and is now registered in EUDAMED with the reference SRN: FR-MF-000058145. This milestone marks a significant step in the deployment of digital therapeutics for cancer support across Europe.
What This Certification Means
CE marking under the European Medical Device Regulation (EU MDR 2017/745) is a rigorous certification that confirms a medical device meets the safety, performance, and quality standards required for the European market. For digital health solutions, this is not a formality — it is a demonstration of clinical rigor and regulatory credibility.
EUDAMED (European Database on Medical Devices) registration makes RESIL.IO Health visible and traceable across the EU regulatory landscape. It signals to healthcare providers, payers, and patients that the solution has undergone the scrutiny required to operate as a legitimate medical device — not just a wellness app.
What Is RESIL.IO Health?
RESIL.IO Health is a digital companion designed for women on adjuvant hormone therapy following breast cancer treatment. Hormone therapy — typically lasting 5 to 10 years after primary treatment — is one of the most effective tools for reducing recurrence risk. It is also one of the most challenging to sustain.
Side effects of hormone therapy include joint pain, fatigue, hot flashes, mood changes, and sleep disturbances. These effects are a leading driver of treatment discontinuation — with studies showing that up to 50% of women do not complete their prescribed course. The consequences for recurrence risk are significant.
RESIL.IO Health addresses this challenge by providing:
- Daily quality of life tracking to monitor side effects in real time
- Personalized support content to help women manage symptoms
- Medication adherence support to reduce unintended discontinuation
- Data that can support clinical follow-up conversations
Available in France and Belgium
RESIL.IO Health is now available to patients in France and Belgium. With CE marking secured, the path to broader European deployment is open — both in terms of regulatory authorization and insurance reimbursement pathways.
This is particularly relevant in France, where RESIL.IO Health is already listed in the Elsee.Care reimbursement network under « soins de support cancer, » enabling up to 80% reimbursement for eligible patients. This makes it one of the few digital health solutions for cancer support with both regulatory clearance and an active reimbursement pathway.
Why Regulatory Credibility Matters in Digital Health
The digital health market is crowded. Thousands of apps claim to support health outcomes, with varying levels of evidence, transparency, and accountability. In this context, CE marking and EUDAMED registration are more than bureaucratic milestones — they are signals of trustworthiness.
For oncologists, pharmacists, and care coordinators considering whether to recommend a digital tool to their patients, regulatory status is a critical factor. It answers the fundamental question: has this been validated to the standards required of a medical device?
For patients, it provides reassurance that the solution they are using has been designed with their safety and clinical benefit in mind — not just engagement metrics.
The Bigger Picture: Digital Therapeutics in Oncology
RESIL.IO Health’s CE marking is part of a broader movement toward evidence-based digital therapeutics in oncology. As healthcare systems face growing patient volumes, constrained clinical time, and the challenge of supporting patients between appointments, tools like RESIL.IO Health fill a critical gap.
The goal is not to replace clinical care — it is to extend it. To ensure that the conversation between a patient and her oncologist isn’t the only moment of support in a week. To put data in the hands of care teams that helps them have more informed, more productive conversations.
This is what responsible digital health innovation looks like. And CE marking is an important part of making it real.
MG Innovate supports MedTech and e-health companies in strategy, regulatory navigation, and market access across Europe.