Transparency Portal

1. Manufacturer Identification

2. Marketed Medical Devices

3. Regulatory Compliance

3.1 — Regulation (EU) 2017/745 (MDR)

The Digipark and Digipark 360 devices comply with Regulation (EU) 2017/745 on medical devices. As Class I devices, they are subject to self-certification and a CE declaration of conformity established by the manufacturer.

The technical documentation is kept available to competent authorities in accordance with the requirements of Annex II and Annex III of the MDR.

3.2 — GDPR Compliance

DiamPark complies with Regulation (EU) 2016/679 (GDPR). A Data Protection Officer (DPO) has been appointed. A Data Protection Impact Assessment (DPIA) has been carried out for each device. For more information, see our Privacy Policy.

3.3 — Health Data Hosting (HDS)

Health data collected by DiamPark devices is hosted by an HDS-certified host (Health Data Host) in accordance with Article L.1111-8 of the Public Health Code. Hosting is carried out in France.

3.4 — Digital Health Agency (ANS)

DiamPark devices comply with the recommendations of the ANS (Agence du Numérique en Santé), in particular the interoperability and security framework for digital health services and solutions.

4. Medical Device Vigilance

DiamPark has a medical device vigilance system compliant with Articles 87 to 92 of Regulation (EU) 2017/745. Any serious incident or trend toward an increase in incidents is reported to the ANSM (French National Agency for the Safety of Medicines and Health Products) within regulatory timeframes.

4.1 — Types of incidents to report

• Any malfunction or deterioration of the application
• Any inadequacy of the labeling or instructions for use
• Any incident that has caused or could cause death or serious deterioration of the health of a patient, user or other person

4.2 — Processing procedure

Each report is analyzed by DiamPark's quality team. Corrective and preventive actions (CAPA) are implemented as appropriate. The user who made the report is informed of the follow-up of their report.

5. Post-Market Surveillance (PMS)

DiamPark has implemented a Post-Market Surveillance system compliant with Article 83 of the MDR. This system includes:

• Proactive and systematic collection of data on the quality, performance and safety of the devices
• Analysis of user feedback and reports
• Regulatory and normative monitoring
• Periodic review of technical documentation
• Post-Market Clinical Follow-up (PMCF)

A Post-Market Surveillance Report (PMS Report) is established and updated annually.

6. Clinical Evaluation

The clinical evaluation of DiamPark devices is carried out in accordance with Annex XIV of the MDR and MDCG 2020-1 and MDCG 2020-5 guidelines. It is based on:

• A systematic review of the scientific literature
• Data from own clinical studies (interventional and observational studies)
• Post-market surveillance data
• Benefit/risk ratio assessment

7. Instructions for Use (e-IFU)

Electronic instructions for use (e-IFU) are available online for each device:

8. Safety Recalls (FSCA / FSN)

This section lists any field safety corrective actions (FSCA) and field safety notices (FSN) relating to DiamPark devices.

9. Additional Documentation

10. Contact