How does the GUDID and UDI work
UDI – Defined
Unique Device Identification (UDI) is a system to mark and identify medical devices via bar codes by the ‘labeler’ in America, or ‘manufacturer’ in Europe, within the healthcare supply chain.
GUDID – Defined
The Global Unique Device Identification Database, also known as “GUDID”, is a database created by the U.S. FDA to register all medical devices marketed and sold in the US market. With the deadline extended until September 2020 for Class I devices, these labelers are facing a huge challenge compared to their Class II and Class III counterparts who had to submit much lower volumes of UDI records before September 2018. Class II and Class III devices were often submitted using manual methods either via direct data entry or Excel spreadsheet uploads to the FDA’s Electronic Submission Gateway (ESG).
EUDAMED – Defined
Europe’s Medical Device Regulation (MDR), brings widespread and complex changes to how medical devices gain and maintain approval across the European Union. With the intent of enhancing patient safety, key elements of the new MDR include the expansion of the definition of medical devices; enhanced vigilance, market surveillance and traceability measures.
A centralized European Database for Medical Devices, also known as “EUDAMED”, will be created by March 2022. The first expected deadline for compliance with MDR is May 2020 for certain Class I devices, actor registration, conformity assessments, product certification, device registration and supporting documentation are still required. This includes assigning Basic UDI-DI and SSCPs, etc. We advise medical device manufacturers to continue investing in the implementation of EUDAMED to plan properly for M2M testing once new timelines are released by the Commission.
Complying with GUDID
To optimize the process for GUDID compliance, we recommend the following four Critical Action Items:
- Create a Syndication Hub to submit product/device data that can be trusted by your healthcare providers and the FDA
- Aggregate your internal product master data from multiple sources into this single repository, the Syndication Hub, for data validation and submission
- Enrich & validate the product data based on the FDA-specific attributes, code value lists and validation rules
- Submit your validated data to the GUDID using an FDA‑approved “Third-Party Submitter” solution
Complying with EUDAMED (subject to change)
As the Technical Specifications for EUDAMED have not been published, the process for submitting EUDAMED data is still to be finalized. Based on existing knowledge, we expect the following five Critical Action Items:
- Create a centralized repository, a “Syndication Hub” to submit product/device data and documents that can be trusted by your healthcare providers and the regulatory agencies
- Aggregate your internal product master data from multiple sources into this Syndication Hub for data validation and submission
- Aggregate your forms, documents and reports from multiple sources into this Syndication for linking to the Single Registration Number (SRN) and Basic UDI (BUDI) for submission
- Enrich & validate the product data based on the EU-specific attributes, code value lists and validation rules
- Submit your validated data to the EUDAMED using an approved regulatory submission solution
Chat with Innovit experts about how we can help you meet these upcoming compliance dates.
United States FDA: GUDID
United States FDA: UDI Compliance
HIBCC (Health Industry Bar Code UDI Standards)
GS1 UDI Resource Page
Innovit UDI Multi-Connector
Fact Sheet for Medical Device Manufacturers (PDF)
No-Deal Brexit – Implications to MDR
Medical Device Regulations – Countdown
8 Things You Should Know about the EU MDRs