MDR compliance made manageable
The EU Medical Device Regulation (MDR) (EU) 2017/745 sets rigorous standards for medical device safety and traceability. AssetTracker Pro helps you meet those requirements with UDI tracking, supplier verification, and full audit trails - without disrupting your existing workflows.
What is the Medical Device Regulation?
The European Union's Medical Device Regulation (EU) 2017/745 governs the design, manufacture, and distribution of medical devices within the EU. It ensures that devices meet rigorous safety and performance standards, protecting patients and healthcare providers alike.
One of the most significant changes under MDR is the increased level of scrutiny and oversight. Manufacturers must demonstrate that their devices meet strict standards and provide detailed information about design, testing, and clinical evaluation.
For hospitals and healthcare organisations, non-compliance can result in administrative fines, penalties, or legal action. ATP is built to help you stay compliant, confidently.
What ATP helps you achieve
- check_circle Unique Device Identification (UDI) for every medical device
- check_circle Supplier verification against AccessGUDID, EUDAMED and internal databases
- check_circle Full traceability from manufacturer to patient bedside
- check_circle GS1, HIBCC, ICCBRA and IFA barcode standards supported
- check_circle GDPR-compliant data security and access controls
- check_circle Audit-ready reporting for regulatory inspections
MDR compliance features built into ATP
Every ATP deployment includes these MDR-ready capabilities as standard.
UDI Scanning
Scan GS1, HIBCC, ICCBRA and IFA barcodes automatically. ATP identifies the standard and processes UDI data without manual input.
Supplier Verification
Verify assets against AccessGUDID, EUDAMED, or your own inventory database on first scan. Non-compliant products are flagged automatically.
Full Traceability
Track every device from manufacturer to patient - including repairs, maintenance, modifications, and location history.
Audit Trails
Every scan, action, and change is recorded with timestamps and user attribution. Generate compliance reports at any time.
Data Security
End-to-end encryption, role-based access, and GDPR-compliant data handling. Only authorised users can access sensitive device data.
Reporting & Analytics
Custom reports, RAG alerts, and KPI dashboards help you monitor compliance status and identify trends across your organisation.
Build your MDR workflow from pre-built modules
ATP includes pre-built modules for common healthcare processes. Mix, match, or customise - the choice is yours.
Asset & Inventory Management
Track stock levels, manage reordering, and maintain accurate inventory records across departments.
Workflow & Process Management
Digitise standard operating practices into step-by-step workflows with version control and preview releases.
Auditing & Compliance
Granular audit trails on every piece of data, grouped into custom compliance reports at any frequency.
Need to demonstrate MDR compliance?
We can help you assess your current processes and show you how ATP bridges the gap between legacy systems and MDR compliance. Book a free consultation.
No hard sell • A real engineer on the first call