MDR Compliant Solution
To meet the European Medical Device Regulation (MDR), which replaced the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), medical devices must carry a unique device identifier (UDI). The regulations have been introduced to improve patient safety, product quality and traceability accuracy. With an MDR compliant solution in place, medical devices can be tracked throughout the supply chain.
Industrial Technology Systems Ltd (ITS) offers a range of compliant UDI automation solutions to assist medical device manufacturers in meeting the MDR regulatory requirements. The solutions can include any of the following services and solutions:
- Production of UDI User Requirement Specifications
- Automation solutions integrated with ERP or database(s) to receive work flows and associated UDI data
- Integration of label management solutions offering a full audit trail, approval process and archiving
- Installation of print management solutions
- Design and implementation of vision systems and code readers to verify that any data printed on each device or label is eligible and correct
- 21 CFR Part 11 and CFR Part 820 compliant database solutions to record the UDI traceability data applied to each product for each batch for reporting purposes with audit trail
- Validation services for UDI automation solutions
- Provision of UDI consultancy
- Integration of UDI compliant solutions with production systems e.g. OEE, situational awareness to improve operational performance
ITS’ team has been working in the medical device industry since the company started in 1991. Since then we have gained extensive experience in offering fully validated automated solutions to improve product quality, patient safety, traceability and MDR compliance.
The solutions are flexible and can be integrated with different ERP systems to automatically receive work-flows and UDI data. The solutions are designed to improve product quality by automatically inspecting products and labels and accurately tracking medical devices throughout the entire production process.
The MDR compliant systems integrate with label and print management solutions, to ensure that the right label and data is applied to each device. As an independent company, ITS works closely with its medical device clients to understand their requirements and recommend the best solutions to help them achieve regulatory compliance.