Background and Problem
A US based manufacturer of sample preparations reagents and instruments needed an outside opinion of their regulatory compliance regarding labeling certain devices as “Research Use Only (RUO)” in the United States and the European Union. The manufacturer also wanted assistance to develop an approach on how best to register and list a large group of devices in the US database and information on Unique Device Identified (UDI) requirements in both the US and EU. Without this clarity, the manufacturer risked compliance issues.
Approach
AlvaMed used a comprehensive approach to address the manufacturer’s challenges:
- Product Use and Distribution Assessment: AlvaMed collaborated with the client to understand the intended use, distribution channels, and risk profiles of each device.
- Regulatory Expertise: AlvaMed leveraged its in-depth knowledge of US and EU regulations, including applicable guidance documents, recent FDA rules, and IVDR (In Vitro Medical Device Regulations) requirements.
Results
The collaboration with AlvaMed delivered significant benefits for the manufacturer:
- Clear Classification: AlvaMed’s expert assessment helped the manufacturer to categorize their devices as either RUO or as in vitro diagnostic devices . This clarity allowed the manufacturer to:
- Streamline Regulatory Processes: Focus resources on the appropriate registration and listing procedures for each device category in the US and EU, thus saving time and effort.
- Reduce Compliance Risks: Ensure their labeling and marketing activities adhered to the regulations specific to each device category, minimizing the risk of non-compliance issues.
Key Takeaway
- Seek Expert Guidance: Navigating the intricacies of global medical device regulations can be complex. Partnering with a regulatory consultant like AlvaMed can provide manufacturers with the expertise needed to ensure compliance.
