With the 27 November 2026 EUDAMED deadline for legacy devices fast approaching, manufacturers are running out of time to identify gaps, validate data, and complete required registrations. While EUDAMED is often viewed as a database, compliance requires accurate coordination of product, UDI, actor registration (SRN), and certification data across multiple modules.
This webinar is designed for organizations that need practical guidance, not theory. You’ll learn what actions manufacturers should prioritize before November, the most common mistakes that delay approvals, and how to build a focused plan to reduce compliance risk and avoid last-minute surprises.
Key takeaways include:
- What manufacturers must complete before the November deadline
- The roles of manufacturers, Notified Bodies, and Authorized Representatives
- Why data preparation is often the biggest challenge
- Manual entry vs. XML bulk upload considerations
- Common registration mistakes and how to avoid them
- A practical readiness checklist for the final months before the deadline
Join us to gain a clear understanding of where to focus your efforts, avoid costly delays, and move toward EUDAMED compliance with confidence.
For Medical Device Establishments, who must register?
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
What information is submitted for medical device establishment registration?
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.
