Transition to IVDR with EQMS
On May 26, 2022, In Vitro Diagnostic Directive (IVDD) will be replaced by In Vitro Diagnostic Medical Device Regulation (IVDR), introducing a new approach to how in vitro diagnostic devices (IVDs) will be regulated in the European Union (EU). In Vitro Diagnostic Medical Device Regulation (IVDR) replaces the previous IVD directives to enable reliable and effective IVDs. The amended directives include regulatory changes and requirements to enhance the safety and efficacy of IVDs for non-EU manufacturers and economic operators with commercial operations in the European Economic Area (EEA).
Article 10 of IVDR mandates a quality management system to ensure that manufacturing, change control, customer complaints, resource management, supplier and subcontractor controls and validation, performance evaluation, quality test, UDI labeling, post-market surveillance, etc. are according to the approved QMS and Post-Market Surveillance (PMS) plans. Implementing a pre-validated Enterprise Quality Management System (EQMS) will undoubtedly make life easier for quality leaders who are gearing up to meet the stringent and complex requirements of IVDR.
A six-step approach to meet IVDR using EQMS
Improved Products and Business
- Innovate with an adaptable quality platform
- Drive continuous improvement and business growth
- Deliver exceptional customer experiences to build customer loyalty
- Leverage your data for a factual approach to decision making
- Gain greater efficiency by getting things right the first time
- Reduce variability of materials, waste, and rework to cut time and costs
- Keep quality processes repeatable to increase knowledgeable staff and reduce human error
- Prevent delays by minimizing disruptions to stay on time and under budget
- Improve process control to minimize quality gaps
- Reduce lead time and increase production yield
- Ensure quality standards are being met
- Experience total traceability
- Turn insights into action
- Provide historical audit trails to speed compliance
- Become adaptable to changing or emerging market conditions and to environmental and other government regulations.
- Provide visibility between your quality processes, product record, requirements, issues, and related processes
- Enable teams to confirm designs easily, adjust plans, and resolve issues fast
- Quickly find the root cause and speed up resolution
- Predictive analysis of data reduces the risk of probable quality failure
- Limit damages to profits, reputation, and existing relationships
Managing the IVDR Transition with ComplianceQuest EQMS
For a successful outcome, manufacturers, including economic operators (Importers, Authorized Representatives, Distributors) must work closely and cooperate with the Notified Bodies, suppliers, and sub-contractors of the European Commission and Competent Authorities to ensure the legislative framework is successfully adopted, and safe products are continually available to the patients in need.
ComplianceQuest’s EQMS solution is designed to manage the entire product lifecycle right from well-established technical documentation, procedures, document management, change control, design control, CAPA, etc. This can help meet IVDR requirements more intuitively and enable automating the various quality areas, assisting auditors in evaluating the process, data quality, and integrity.
Some of the ComplianceQuest EQMS’s features that facilitate IVDR transition include:
A next-generation, cloud-based EQMS like ComplianceQuest will make it easy to ensure people, processes, and systems are genuinely connected. It will help enhance productivity, streamline collaboration, and ensure seamless flow of information across the organization. ComplianceQuest’s cloud-based EQMS provides real-time data analysis and updates that play a crucial role in being 24/7 audit-ready.
Digital change management
Unless QMS documentation is digitally managed, change management will be erroneous or would lack updating. ComplianceQuest Document Management Solution enables you to manage the entire document lifecycle and gain complete visibility as you transition to IVDR. With an electronic approach to document management, leaders responsible for this transition to IVDR will have a central repository to create, modify, review, approve, store, organize, access, and share documents globally in a controlled manner.
Suppliers and sub-contractor controls
IVD manufacturers depend on various suppliers to produce and deliver safe, accurate, and effective products for human use. Thus, regulatory and quality concerns are also evolving when it comes to suppliers and subcontractors. Convey the IVDR requirements to the suppliers and ensure new agreements are in place. ComplianceQuest Supplier management solution offers supplier and sub-contractor controls and validation helps avoid the risk of IVDR noncompliance.
Post-market surveillance and vigilance
Manufacturers are required to produce the PMS Plan and Report/Periodic Safety Update Report (PSUR) following the IVDR. A procedure to perform PMS and vigilance should be in place, and it should be continuously updated. A robust and reliable quality management system (QMS) such as the one from ComplianceQuest allows users to have a post-market performance follow up plan.
Internal and external communication
Real-time communication with quantifiable data within and external to the organization is essential. Our QMS module is equipped with effortless communication channel while the system is available on mobile. This facility helps communicate the whole process to all the suppliers, sub-contractors, or service providers and their obligations.