Optical Medical Device Manufacturers – GUDID & UDI – Are You Prepared?

by Innovit Corporate Affairs | September 21, 2020 | Blog

Global Ophthalmic Medical Devices – Meeting Market Demands

According to the Vision Council of America, approximately 75% of adults use some sort of vision correction.    And with the rising number of retail chain stores, optometrists and opticians, the global vision care devices and equipment market (valued at about $27.6 billion in 2018) is expected to grow to $33.68 billion at a CAGR of 5.1% through 2022[1].  That’s good news for optical medical device manufacturers.

Meeting aggressive market demands will require innovative approaches to production and leveraging the supply chain for a competitive advantage.  But in order to do so, optical medical device manufacturers must also meet regulatory and compliance requirements for product data submissions.


Regulatory Requirements – Submitting Product Data

The FDA’s UDI regulations for Class I devices require labeling, direct marking and GUDID submissions are due September 2022.   Note that Class I devices include spectacle frames, Plano sunglasses, over-the-counter reading glasses and many low vision devices.[3]  Additionally, for those manufacturers intending to market prescription eye wear products in the European Union, EUDAMED submission will be due in May 2022.  Additional global regulators are emerging and will require regulatory expertise for UDI submissions.  The challenge in meeting these regulations is ensuring that product data is accurate, complete – and most importantly – “trusted”.


Submitting Product Data – Taking a Closer Look

The sheer volume of products in this category makes manual submission methods too slow. Having high product volumes increases the burden of data collection, data cleansing and data submission to the GUDID (Global UDI Database).  In addition, Class I products tend to change more frequently due to a constant flow of new models and variants.  They also do not require long cycles of clinical trials and performance studies.  Therefore, the risk of failing to meet the FDA’s deadline increases substantially.



GUDID & UDI – Are You Prepared?

The goal of UDI regulations is to help improve patient safety.  The GUDID system was designed by the FDA to facilitate product information exchange between ‘labelers’ and hospitals.  For manufacturers, UDI will improve internal processes and bolster master data quality.  It will provide more accurate reporting and traceability during product recalls.  It was also assist in tracking down counterfeit devices.  Unfortunately, manual submission methods via online data entry or Excel spreadsheet uploads are time‑consuming and error prone.  An automated, machine-to-machine solution will help optical medical device suppliers achieve compliance with FDA UDI requirements in an efficient and cost-effective manner.  Additionally, data validation and submission can be systematically assured, and master data quality can be improved significantly without increasing operational & IT headcount.


It’s Time to Ask…

  • Have you identified the scope of Class I products impacted?
  • Is your data sourced from multiple locations?
  • Is your data accurate and complete?
  • Do you have a formal data governance strategy?
  • Do you have a sustainable process to provide accurate product data to the FDA?
  • Do you have a primary source of truth for product information?
  • Can your product master data be ‘trusted’ by your customers and regulators?


If you’ve answered ‘No’ to any of these questions, it’s time to establish a primary source of product information to ensure that master data you share with the FDA can be trusted and accurate.


Schedule a complimentary consultation to understand more about how to start early and prepare for the UDI Class I Device Deadline of September 2022.

[1] https://www.businesswire.com/news/home/20191112005955/en/Global-Vision-Care-Devices-Equipment-Market-Report


[2] https://www.seattletimes.com/nation-world/new-focus-on-global-need-for-eyeglasses/