Preparing for Europe’s New In Vitro Diagnostic Medical Device Regulation

The Essential Guide to EU IVDR Compliance

Section 6: How Arena Can Help

As you start to revisit your current quality processes and compile all the necessary product data for IVDR compliance, you may find it overwhelming to manage, especially if you are working with manual, paper-based, or siloed systems.

Quality - Product Using an enterprise quality management system (eQMS) like Arena’s cloud-based QMS reduces the burden of meeting compliance by linking all of your product information and quality processes in one shared platform. Unlike traditional document-based systems, which fail to manage the complete product record, Arena QMS manages linked relationships between device master records (DMRs), design history files (DHFs), bills of materials (BOMs), approved manufacturer/vendor lists (AMLs/AVLs), technical documentation, product history, and any changes or quality issues. This product-centric approach to QMS enables greater visibility, traceability, and control throughout the entire product lifecycle and reduces compliance risks.

With access to a single, unified system, dispersed product teams and supply chain partners can easily collaborate anytime and anywhere. This eliminates silos and enables impacted teams to quickly identify, analyze, and resolve quality issues. And because all the performance evaluation reports, post-market surveillance reports, and other technical documentation necessary for IVDR compliance are connected and easily extractable—you can be confident that product data is always accurate and audit-ready. Ultimately, with Arena QMS your team can spend less time managing documents and focus on delivering innovative, safe, and effective products that improve the quality of patients’ lives.

IVDR Requirement	How Arena QMS Helps
Technical File	A Technical File Quality Template enables you to easily build your technical file without having to start from scratch. All the essential IVDR requirements are built into the template, so there’s no guesswork on your end. The technical file is automatically linked to your product record and shows the history of any changes that are made. It can be easily exported for review by your notified body.
Performance Evaluations and Post-Market Performance Follow-up	Quality Templates are provided to help you formulate your performance evaluation plan, performance evaluation report, post-market performance follow-up report, and other critical documents. Performance evaluation and post-market performance follow-up documents are linked to the product record and show the history of any changes that are made. Documents can be easily exported and included with your technical file.
Post-Market Surveillance (PMS)	Quality Templates are provided to help formulate your post-market surveillance plan and reports. PMS plans and reports are linked to your product record and show the history of any changes that are made. Documents can be easily exported and included with your technical file.
Labeling	When initiating change orders for product labels, you can create a Change Order Custom Attribute for impact analysis to help identify all instances where the addition of a UDI and other labeling changes will apply.
Serious Incident and Field Safety Corrective Action Reporting	Quality Templates are provided to help you prepare serious incident and field safety corrective action reports. Reports are linked to your product record and show the history of any changes that are made. Documents can be easily exported and included with your technical file.
Quality Management System (QMS)	Quality Templates are provided to help you develop the necessary processes and procedures for your QMS. Quality documents are linked to your product record and show the history of any changes that are made. Documents can be easily exported and included with your technical file.