Authority starts with the source, not with ClinicOps.
ClinicOps works from official public authorities, legislation and source systems. Guidance is kept distinct from binding law, public records from client-controlled sources, and missing public data is never read as a compliance conclusion.
Denmark
- Danish Medicines Agency — medical devices
Danish medical-device legislation, national implementation, market surveillance and guidance within the MDR/IVDR framework.
- Danish Medicines Agency — medicinal clinical trials
National CTR/CTIS trial information and Danish authority processes.
- Danish Patient Safety Authority — health-professional authorisation
Authorisation and professional-status information for regulated health professions.
- Danish Authorisation Register
Public verification of Danish healthcare-professional authorisation status.
- Danish Patient Safety Authority — healthcare-facility supervision
Treatment-place supervision and patient-safety governance where clinical delivery is in scope.
- National Center for Ethics / Medical Research Ethics Committees
Ethical-review sources for Danish research, medicinal trials and clinical investigations where applicable.
- Danish Data Protection Agency
Official Danish GDPR and data-protection guidance, including health-data contexts.
- Danish Health Data Authority
National health-data infrastructure, standards and digital-health source material.
European Union / EEA
- European Commission — MDR/IVDR framework
The Commission’s official MDR and IVDR pages.
- European Commission — EUDAMED
Official EUDAMED status, modules, rollout and guidance. The first four modules became mandatory from 28 May 2026.
- European Commission — MDCG guidance
Officially hosted MDCG and related implementation guidance; guidance is not treated as legislation.
- European Commission — Clinical Trials Regulation / CTIS
EU clinical-trial regulatory framework and CTIS context.
- European Medicines Agency — ICH E6 Good Clinical Practice
Current EU GCP guideline source and implementation information.
- European Commission — AI Act
Official EU AI Act policy and implementation material.
- European Commission — high-risk AI guidance
Commission guidance material for high-risk classification and implementation; status is read at source before use.
- European Commission — European Health Data Space
Official EHDS regulation implementation and timeline information.
- EUR-Lex
Authoritative access point for EU legislation and Official Journal material.
Standards and controlled sources
Where a workflow depends on standards such as ISO 13485, ISO 15189 or ISO/IEC 42001, ClinicOps records the relevant edition and source but does not reproduce copyrighted standards text. Client-controlled SOPs, QMS records, trial documents, IFU, labels, SS(C)P, RIM data and other approved records remain separate from public-source evidence.