Country-Specific UDI Compliance – Staying Up to Date on Changing Deadlines

by Ashley Howell | April 14, 2021 | Blog

UDI Timeline: A progression of UDI compliance regulations and deadlines.

One thing in healthcare is certain: patient safety and quality of care will continue to drive change in the healthcare market. UDI regulations support this objective and deadlines for implementation are looming.

Every “labeler” of medical devices in America is required to maintain UDI data and submit this information to the FDA’s GUDID. Devices are grouped into three risk classifications (Class III, Class II, Class I) – each class with different submission deadlines.  (Note that for the equivalent European regulation, the responsibility for UDI submission lies with the “manufacturer” of a medical device)

Today, medical device manufacturers understand the benefits of the FDA GUDID and many are now fast‑tracking the adoption of UDI regulations in their respective jurisdictions, including the European Union and China (with the upcoming EUDAMED and NMPA UDID systems).  

However, it’s a changing landscape and the entire process can present a host of major challenges as companies adapt and move forward.  As a medical device manufacturer, it’s important that you stay up to date.   

Yet, with so much happening in our world today, updated compliance deadlines can be easy to miss. We’re here to help with an update on the UDI with a country-specific UDI compliance timeline (infographic).

Once you have a handle on the deadlines most relevant to your business, the next step is to learn about different UDI implementation strategies.  We recommend developing a ‘globally’ scalable process for submitting product data to FDA’s GUDID, EUDAMED or any other regulatory database.  To optimize your process for GUDID compliance, we suggest the following four critical actions.

  • Create a Global Data Syndication Hub (GDSH) to aggregate product/device data from various source systems
  • Aggregate your internal product master data from multiple sources into the Syndication Hub, for data cleansing, enrichment, validation and submission
  • Enrich and validate the product master data based on FDA-specific attributes, code value lists and data validation rules
  • Submit your validated data, that can be trusted by the FDA and your healthcare customers, to the GUDID using a Third-Party Submitter solution that supports HL7/SPL messaging standards, 21 CFR Part 11, and GAMP5 system validation requirements

 

Innovit’s UDI compliance and PIM (Product Information Management) solutions can help you overcome these challenges by allowing medical device suppliers to implement a “global system and unified process” that is fully integrated with internal systems to submit regulatory data to multiple regulatory databases simultaneously.  

The ongoing confusion regarding the UDI deadlines still persists as each country/market continues making changes along the way.  Fortunately, we’re here to help.

Check out our NEW country-specific infographic detailing the UDI Compliance deadlines you need to know.

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