Futura Medtech ("we", "us", "the manufacturer") is the data controller for the personal data processed through this electronic Instructions for Use ("eIFU") portal. This notice explains what we collect, why, and your rights under the EU General Data Protection Regulation (GDPR) and equivalent local laws.
1. What we collect
When you look up an Instructions for Use document, we automatically record:
- Your IP address and approximate country (derived from the IP).
- The product code and batch number you entered.
- The IFU document and language you viewed.
- The time and outcome of the request.
When you submit a paper-copy request we also collect the contact and shipping details you provide (name, email, phone, organisation, address).
2. Why we collect it
We process this data for two purposes:
- Regulatory vigilance and audit. EU Regulation 2021/2226 requires manufacturers to record access to eIFU documents so that we can detect issues with availability, language coverage, and product safety. Legal basis: legal obligation and legitimate interest.
- Fulfilling paper-copy requests. Legal basis: performance of a legal obligation (EU Regulation 2021/2226 Art. 6).
3. How long we keep it
- Access logs: for the lifetime of the device plus at least two years (per Reg. 2021/2226 Art. 5).
- Paper-copy requests: ten years (per medical device record-keeping norms).
4. Who has access
Only authorised personnel of Futura Medtech can access this data. We do not sell or share personal data with third parties for marketing. Hosting and email delivery providers process data under contractual data-processing agreements.
5. Your rights
You have the right to access, correct, or request deletion of your personal data, to object to processing, and to lodge a complaint with your national supervisory authority. Send requests to regulatory@futuramedtech.com.
6. Cookies
We only use strictly necessary cookies — session and CSRF protection. See our Cookie Notice for details.
7. Contact
Questions about this notice or our data practices: regulatory@futuramedtech.com.