📊🩺 In Vitro Diagnostic Regulation (IVDR): What You Need to Know – Part 2

📊🩺 In Vitro Diagnostic Regulation (IVDR): What You Need to Know

Laboratory-Developed Tests (LDTs) Compliance 🧪:
From May 26, 2022, LDTs within health institutions must comply with General Safety and Performance Requirements (GSPR). Manufacturers should prioritize compliance and registration for a seamless transition.

FDA Updates on LDTs 🇺🇸:
The U.S. FDA issued its Final Rule on Laboratory-Developed Tests (LDTs) on April 29, 2024. This marks the end of the enforcement discretion policy, and LDTs are now regulated as medical devices. A four-year phased implementation is in place.

Your Action Plan: Staying Compliant

1. Conduct a Gap Analysis 🔍: Evaluate your product portfolio and identify areas of non-compliance.
2. Gather Clinical Data 📑: Ensure robust clinical evidence supports device performance.
3. Engage Early with a Notified Body 🏅: Start the certification process promptly.
4. Implement Risk-Based Management ⚠️: Align internal processes to the new regulatory landscape.
5. Prepare for UDI Implementation 📦: Ensure seamless traceability for all devices.
6. Focus on Quality Systems ✅: Set up compliant quality management systems (QMS).
7. Post-Market Surveillance 👁️‍🗨️: Adopt proactive monitoring practices.
8. Register in EUDAMED 🖥️: Ensure all economic operators meet registration requirements.

Need Help?
Navigating regulatory updates can be complex. Let our team of regulatory experts help you streamline the transition, so you can focus on innovation and patient care. 🤝

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