As the European Union moves toward full EUDAMED implementation, medical device manufacturers face a critical shift from regulatory awareness to operational execution. With key deadlines in May 2026 for new devices and November 2026 for legacy devices, organizations must ensure their data, systems, and processes are fully aligned to meet compliance requirements before market access is impacted.
Despite being viewed as a simple database, EUDAMED requires coordinated, accurate data across multiple modules—placing full responsibility on manufacturers for UDI submissions, actor registration (SRN), and alignment with Notified Body certificates.
In this webinar, we will provide a practical roadmap to EUDAMED compliance, including:
- How EUDAMED’s 6-module ecosystem functions and what is required from manufacturers
- The true responsibilities of manufacturers vs. Notified Bodies and Authorized Representatives
- Why data preparation—not submission—is the biggest barrier to compliance
- The risks of manual entry vs. XML bulk upload, and how to choose the right approach
- The most common registration mistakes that delay approvals
- How to build a structured internal readiness plan to meet 2026 deadlines with confidence
Join us to learn how to reduce risk, streamline registration, and ensure uninterrupted access to the EU market.
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.
