Project status: Independent, evolving educational and evidence-navigation project; public pre-commercial release.

Regulatory status: Not currently CE-marked as a medical device. Formal software qualification and classification are under assessment.

Primary users: Physicians, residents and other appropriately trained oncology professionals.

Data architecture: Local-first case processing; current clinical case data are not transmitted to radioterapie.eu.

1. Intended purpose

radioterapie.eu Clinical Navigation Tools are intended to help appropriately trained oncology professionals learn, organize relevant case information, understand the biological and evidential basis of recommendations, compare identified European and national practice contexts, perform transparent educational calculations and prepare non-authoritative case or tumour-board summaries.

They are intended to make reasoning, missing information, assumptions, source provenance, uncertainty and alternative pathways more visible. They are not intended to replace official clinical systems or multidisciplinary responsibility.

2. Uses outside the current intended purpose

The current release is not intended to:

•  establish or exclude a diagnosis;
•  autonomously select, prescribe or deliver treatment;
•  provide a guaranteed prognosis or outcome;
•  replace clinical examination, pathology, imaging, laboratory interpretation or specialist consultation;
•  serve as the sole calculation or verification system for radiotherapy prescription, planning or cumulative dose;
•  monitor a patient or generate alarms;
•  function as the official medical record; or
•  be used by patients as a substitute for professional medical advice.

3. Regulatory position

The software is presently made available as an educational and evidence-navigation project and does not bear a CE mark as a medical device. No statement on this website should be interpreted as a declaration of conformity or regulatory certification.

Because some modules process patient-specific clinical variables and may display treatment-relevant options or calculations, the publisher is conducting a formal assessment under Regulation (EU) 2017/745 and current European medical-device-software guidance. Intended-purpose language, promotional claims and future commercial functions will be controlled as part of that assessment.

Until that work is completed and any required conformity route is satisfied, the tools must not be represented or used as certified autonomous clinical decision software.

4. Evidence governance

The project uses the following principles:

•  Source traceability: material recommendations should be linked to identifiable official guidance or primary evidence.
•  Versioning: each module displays its own software/evidence version or review date.
•  Source hierarchy: official regulatory and safety information, current professional guidelines and consensus documents are distinguished from systematic reviews, trials, observational studies and institutional pathways.
•  National overlays: country- or centre-specific sources supplement rather than silently replace the European evidence core.
•  Conflict visibility: meaningful disagreement, uncertainty and lack of source coverage should be displayed rather than averaged away.
•  No silent incorporation: a newly published item identified by the Radar does not alter a module until it has been appraised, mapped, tested and released.
•  Reproducibility: deterministic clinical logic should produce the same result from the same version and inputs.

5. Review and update cycle

A structured guideline and source audit is planned at least quarterly. Important regulatory safety communications, practice-changing evidence and correction of identified errors may trigger an earlier review. The date displayed by a module describes its own evidence snapshot; it is not a promise that every linked source remains unchanged.

6. Verification and validation status

Development uses structured rule review, source mapping, demonstration cases, regression tests, self-tests, version control and change records. These measures reduce avoidable inconsistency but do not, by themselves, constitute independent clinical validation, conformity assessment or certification.

Before commercial clinical deployment, the project intends to establish a controlled product definition, risk-management process, evidence-to-rule traceability, software lifecycle documentation, cybersecurity controls, formal verification and validation, and an appropriate post-release surveillance process.

7. Known limitations

•  Coverage is selective and may omit a relevant guideline, jurisdiction, treatment, trial, centre or reimbursement rule.
•  Guidelines can lag behind evidence and can differ because of population, resources, regulation or methodology.
•  Local availability, expertise, waiting time, funding and reimbursement must be verified with the responsible centre or payer.
•  Outputs depend on accurate and complete inputs; missing or ambiguous information may change the interpretation.
•  Models and calculators simplify biology and may be invalid outside their stated assumptions.
•  External links, trial records and institutional documents may move or change without notice.
•  The software cannot account for every comorbidity, preference, interaction, competing risk or multidisciplinary consideration.

8. Guideline comparator interpretation

Country comparison applies the same entered case to the identified contexts and separates encoded national rules from areas where current source coverage is incomplete. “Not computed,” “not covered” or absence of a displayed difference must never be interpreted as agreement between countries. The official current source remains authoritative.

9. Privacy and cybersecurity

Current patient case data are processed locally. Ordinary website technical data, consent information, contact messages, accounts and subscriptions are separate processing activities described in the Privacy Policy. Users must secure their devices and exported reports and must not transmit identifiable patient information through feedback or subscription channels.

10. Reporting an error or safety concern

Suspected clinical, scientific, calculation, source, privacy or interface problems should be reported through the Contact page. Please provide the module, version, relevant source and a de-identified description. Do not submit names, dates of birth, record numbers, images or other identifiable patient information.

If an output appears unsafe, inconsistent or implausible, do not rely on it. Verify the matter independently and follow the responsible institution’s safety process.

11. Independence, funding and conflicts

radioterapie.eu is an independently developed and self-funded project. No guideline publisher, professional society, hospital, university or cited commercial organization endorses the tools unless an explicit written partnership is stated. Material financial support, commercial relationships and contributor conflicts relevant to a module will be disclosed.

12. Changes and version history

The intended purpose, limitations and regulatory position are controlled information. Material changes will be dated and reflected across the About page, tool banners, this page, future app-store descriptions and commercial material. A public change log will be added to each module, linked to the version number.

Last reviewed: 27 August 2026.