The European Commission’s In Vitro Diagnostic Regulation (EU IVDR 2017/746), which is going to be effective from 26 May 2022, is a ‘legislative framework’ that is slated to replace the earlier IVD Directive (IVDD). Unlike IVDD which is a directive, IVDR is a legislation applicable to all Economic Operators (EO) including manufacturers, importers, users, notified bodies and national authorities.
The new regulation is designed to improve the quality and safety of IVD Devices and emphasizes on the need for greater data visibility, transparency and traceability across the value chain.
Meeting IVDR requirements will be easier with a cloud-based EQMS
As various organizations gear up to meet IVDR requirements, there is one aspect that is non-negotiable: The need to implement and certify a reliable Quality Management System.
Although this is not a new requirement for organizations globally, the general obligation of a manufacturer, as detailed in Article 10 of IVDR, mandates the implementation of a Quality Management System to ensure that quality and compliance requirements are met across the following processes:
- Change control
- Customer complaint handling
- Resource management
- Supplier and sub-contractor controls and validation
- Performance evaluation
- Quality tests
- UDI labelling
- Post-Market surveillance
Implementing a pre-validated Enterprise Quality Management System (EQMS) will certainly make life easier for quality leaders who are gearing up to meet the stringent and complex requirements of IVDR. A next-generation, cloud-based EQMS like ComplianceQuest will make it easy to ensure people, processes and systems are truly connected. It will help enhance productivity, streamline collaboration and ensure seamless flow of information across the organization.
Our recent whitepaper deep dives into the In Vitro Diagnostic Regulation (EU IVDR 2017/746) ‘legislative framework
An integrated solution for document, change and risk management
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.
Additionally, the ComplianceQuest Change Management Solution can automate the change management process of transitioning to IVDR. Specifically, the Change Management solution will automate the process of change initiation, change evaluation, change execution & tracking, in addition to change verification & closure.
IVDR focuses on a risk-based approach for the classification of devices requiring increased regulatory oversight. The regulation identifies four risk classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk). Annex VIII defines seven classification rules to correctly classify the products. Depending on the intended use of the device and risk class, manufacturers will need to identify a designated Notified Body and choose the most appropriate conformity assessment route to demonstrate compliance with the regulation.
With ComplianceQuest EQMS, quality and compliance leaders have an integrated risk management solution that is designed for risk mitigation and continuous monitoring. It will help streamline the process of mitigating risks associated with the transition to IVDR. The solution will automate the entire process of risk intake, risk assessment & analysis, risk mitigation, risk monitoring, and enable a collaborative effort to mitigate risks.
QMS Certification (where relevant) requires companies to prepare for an inspection by a Notified Body. Performing IVDR gap assessments will become critical and will need a streamlined auditing processes with an easy flow of information across the value chain.
As we wrote in a recent blog, IVDR emphasizes a lifecycle approach that doesn’t end with just building the product but continuing to monitor it after the product is released into the market. Manufacturers and other economic operators must actively handle customer complaints and take advantage of data to constantly improve the product. In the case of an adverse event report, a swift Corrective and Preventive Action (CAPA) and Root Cause Analysis (RCA) process is a must — not only to fix the problem at hand but also to gain insight into future problems and to drive continuous improvement.
Overall, manufacturers would do well to embrace a next-generation EQMS like ComplianceQuest that takes advantage of AI and data capabilities to constantly drive improvements and enhancements to all quality-related processes.
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