Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech Life Sciences group and is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in the areas of software development, process management, and data administration with the last 19 years focused on the Life Sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, processing, and submission of Drug Labeling content, Cosmetic information, and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.
EUDAMED UDI Best Practices:
- Think Globally
- Consider incorporating the European Union (EU) into your existing or planned Unique Device Identification (UDI) data solution to ensure a comprehensive and integrated approach. Instead of relying on single-point solutions, which may not be sufficient in today’s global market, including the EU in your UDI data solution can offer significant advantages. Some data elements can be repurposed for each health authority. This will help you comply with EU regulations and ensure seamless product identification and traceability across borders. By doing so, you can effectively manage your product data and reduce the risk of errors while ensuring that your customers receive the highest level of service.
- Start Early and Watch for Updates
- To comply with the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) policies, it is important to understand the intricacies of the EUDAMED database and your Unique Device Identification (UDI) requirements. Familiarizing yourself with these regulations and their timing will help ensure that your medical devices are approved for sale in the EU market and that you meet all requirements.
- To register in EUDAMED, you must create an account and receive an Actor Module Single Registration Number (SRN).
- Self-certify your medical devices in the MDR Class I or IVDR Class A category.
- Please prepare technical documents and initiate certification with the relevant Notified Bodies (NBs).
- Make sure to meet the qualifying deadline for Legacy Devices by May 26th, 2024, to request a QMS and NB contract.
- Please plan and execute the transition of legacy devices to devices that are equivalent or serve as substitutes for MDR. Additionally, plan and execute the transition of legacy devices to equivalent devices or serve as substitutes for MDR.
- Prepare Infrastructure and UDI Data
- Upgrade your systems. This can be time-consuming, so make sure to allocate plenty of time.
- Assign Basic UDI-DI and UDI-DI codes to your products. Basic UDI-DI assignment is a pre-requisite to engaging a NB.
- Collect and Cleanse the EU UDI dataset, which is double the US UDI count, making it more complex.
- You may then submit your UDI data during the voluntary period to your stakeholders’ requests.
For more about the current EUDAMED timeline, visit our updated timeline blog.
For recent news and information from EUDAMED, click here.
Questions about health authorities and Unique Device Identification (UDI)? We monitor health authorities around the globe for the latest requirements and exceptions. If you have UDI questions, we can help. Email us: [email protected] or call +1-215-557-3010