EUDAMED and GUDID – What’s Changed?

The European Database for Medical Devices (EUDAMED)

EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the Eurozone.  The EUDAMED system was stipulated under EU MDR to serve as a repository for important clinical information about medical devices for the European Union market.  It’s a secure, web‑based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

EUDAMED will improve transparency and coordination of product information regarding medical devices available across the European Union.  The system will be multipurpose for pre-market assessment as well as post-market surveillance.  It is designed to function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and will be interoperable across manufacturers, Notified Bodies, national regulators, healthcare providers and consumers.

EUDAMED is structured around six interconnected modules and a public website: Actors Registration; UDI/Device Registration; Notified Bodies and Certificates; Clinical Investigations and Performance Studies; Vigilance and Post-market Surveillance; and Market Surveillance.

What’s changed?  At this moment the European Commission maintains the following timelines:

• Originally slated for a May 2020 go-live date, the deadline was extended to May 2022.
• The Actor Registration module will become available no later than March 2021. This module will allow manufacturers, authorized representatives, importers as well as producers of software systems and procedure packs to:  enter their data into EUDAMED; and to acquire a Single Registration Number (SRN) for economic operators.
• The SRN will be needed for declarations of conformity and certificates.  Therefore the availability of SRNs is considered very important for the proper functioning of the MDR. Note that the SRN must be obtained before the date of application of the MDR,  postponed to March 2021 due to COVID-19.
• In May 2021, two other modules are expected: the UDI / Device Registration module and the Notified Body & Certificates module.
• Other modules for clinical investigations, incident reporting and market surveillance can be released later because they are intended as tools for communication about cases. Current systems can and will be used for such communications until EUDAMED is fully functional.

GUDID

The Global Unique Device Identification Database (GUDID) is a database created by the U.S. FDA to register all medical devices marketed and sold in the United States.  Its intention is to support pre‑market compliance activities for placing medical devices for sale in America.  The deadlines for submitting Class III and Class II devices have already passed.  However, for Class I device data, the deadline – originally scheduled for September 2020 was postponed to September 24, 2022 (due to the impact of COVID-19).

In its guidance, the FDA acknowledged that “preparing to implement UDI requirements while addressing the challenges related to COVID-19 could be very difficult and could divert resources from COVID-19 response efforts”.  The FDA further stated, “To the extent this policy helps labelers remain focused on public health needs related to COVID-19, we believe the policy is further consistent with the public health.”

Next Steps for Compliance

The deadline extension for both EUDAMED and GUDID mean that medical device companies have much more time to prepare.  Rather than implement a short-term band-aid approach, manufacturers and labelers should take the following steps noted below to ensure compliance readiness.

EUDAMED Compliance (subject to change)

As the final Functional Specifications for EUDAMED have not been published nor expected until late October 2020, the process for submitting data to EUDAMED has yet to be finalized.  Based on existing information, we recommend the following five Critical Actions:

1. Create a centralized repository, “Syndication Hub” to submit validated product data and regulatory documents that can be ‘trusted’ by your healthcare providers, EU Commission and national regulators (i.e. the Competent Authorities)
2. Aggregate your internal product master data from multiple sources into the Syndication Hub for data validation and submission
3. Aggregate your forms, documents and reports from multiple sources into the Syndication Hub to establish a relationship to the Single Registration Number (SRN) and Basic UDI (BUDI) for submission
4. Enrich and validate the product data based on EUDAMED-specific attributes, code value lists and data validation rules
5. Submit your validated data to EUDAMED using a ‘proven’ UDI data submission solution^*.

*Note: Innovit has been successfully testing its UDI solution with the EU Commission, having passed multiple rounds of EUDAMED machine-to-machine tests.  We expect to continue testing when the next playground is released by the EU Commission later in 2020. 

It’s important to understand that Innovit was the first – and only company – to successfully test its UDI solution with EU Commission in October 2019.  We were again the only solution to complete all test cases for both MD and IVD categories in February 2020.

GUDID Compliance

To optimize the process for GUDID compliance, we recommend the following four Critical Actions:

1. Create a Syndication Hub to submit validated product/device data that can be trusted by your healthcare providers and the FDA
2. Aggregate your internal product master data from multiple sources into the Syndication Hub, for data validation and submission
3. Enrich and validate the product data based on the FDA-specific attributes, code value lists and data validation rules
4. Submit your validated data to the GUDID using an FDA approved “Third-Party Submitter” solution that supports HL7/SPL messaging standards and GAMP5 system validation requirements