What is the EU EUDAMED Timeline?
The EU EUDAMED Medical Device Registration (MDR) Date of Application (DoA) occurred on May 26, 2021 and the IVDR DoA is May 26, 2022. The Actor Module and UDI/Device Registration and Certificate modules for voluntary use were rolled out. The other three modules (Clinical Investigation, Vigilance and Post-Market Surveillance and Market Surveillance) are in the plan for development. Initial EUDAMED go-live will be a Minimally Viable Product (MVP), with the end of EUDAMED MVP development for all 6 modules slated to occur at the end of 2022.
UDI/Device Registration Module
What Does This Mean for Products Placed on the Market?
Products must be registered for the subsequent requirements that occur when the EUDAMED notice is released (targeted for 2023, indicating the audit has been successful). Once released, a six-month delay is triggered, following EUDAMED officially open for mandatory use. An entire set of clauses then occur, including the beginning of an 18-month mandatory registration period. We recommend submitting voluntary registrations before the mandatory use is in effect, as there are several requirements following thereafter.
- Legacy Devices have a window for products to be placed on the market until May 26, 2024.
- The timeline for Medical Devices is determined by Class, with the Class I device DoA already in effect for Self-Certification submitted to the MDR. Note, UDI on Labels is separate from the device registration time period, a nuance for EU (different than U.S. FDA).
- The DoA for IVDR products is May 26, 2022 (Self-Certification is required).
What to Do Now
- Create UDI Environment – Create UDI Governance Team, identify UDI requirements for your products, evaluate your situation, create UDI plan, prepare UDI infrastructure, establish UDI data solution
- Collect UDI Data – Set up Product ID Standard, assigned Identifiers to portfolio, assemble UDI data, establish governance
- Cleanse UDI Data – Verify data, normalize and validate source UDI data, establish version and approval controls
- Comply with Regulations – Create regulatory account, submit UDI data, verify submission success, maintain data and systems
Reed Tech Provides Valuable Help in Preparing for the EU EUDAMED Launch
Reed Tech provides valuable support in preparing for the inevitable EUDAMED implementation. Contact the Reed Tech Team (or call 1-215-557-3010 / email [email protected]) for more information and explore how Reed Tech can help you meet your global Medical Device UDI data management challenges and requirements.
- Guidance and Expertise – Access subject matter expert UDI knowledge to shape your UDI data management strategy for EU, FDA, other regulators and business partners worldwide
- Data Collection Tools – Efficiently collect EUDAMED data and discover gaps
- System Test Environment – Exercise and verify successful data transfer and import functionality from your system to the Reed Tech system
- Data Cleansing Platform – Support your efforts in ensuring your data meets the EUDAMED data validation rules
- Structured UDI Repository – Manage, control and store your UDI values and attributes in a secure environment from inception to support