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FDA UDI - Lessons for Companies Selling Medical Devices in Europe - Alysidia

November 26, 20200

Before the application of UDI in U.S., the medical device companies could previously identify and track their own devices, but the system was missing a harmonized system to identify device name, device model, and related identifiable information.

The Requesting Body

The AHRMM – American Hospital Association for Healthcare Resource and Materials Management in 2006 asked the FDA to make a unified UDI system for medical devices. It was known afterward that such a medical device identification & tracking system would assist the early detection of device defects, product recalls, and empowers manufacturers’ activities related to post market surveillance.

FDA’s Gradual Approach towards the UDI Implementation

FDA adopted the UDI system in September 2007, as the FDA amendments act of 2007. The FDA published The Final Rule in 2013, which enforced different compliance steps with different dates for UDI complete enforcement. But, the FDA, medical device manufacturers, and the healthcare institutions all had different interpretations and views regarding UDI.

So as to assign the UDI codes; the FDA introduced third parties for instance a global barcoding company (GS1), organization for medical products of human origin (the ICCBBA), and the Health Industry Business Communications Council (HIBCC).

The FDA designed a seven years continual implementation timeline for the UDI system for complete enforcement, so that manufacturers can progressively and comfortably implement. FDA also participated in the Global Unique Device Identification Database (GUDID), which was made as a particular repository to keep device identification (DI) features within a solitary system.

Economic Operators’ Views on FDA UDI

For medical device makers, there were diverse approaches when it came to the new UDI regulations. Some companies were not comfortable with the FDA’s novel enforcement of UDI while many thought that the FDA brought UDI to ascertain the medical device industry would draw alongside with the pharmaceutical industry’s serialization and anti-forgery systems.

The negative attitude towards the FDA UDI was because of the change in labeling and operational settings, which would be needed to have the UDI implemented. But, for all the manufacturers that were exhibiting resistance to UDI, there were many other companies who were celebrating it. Those who were celebrating it; envisioned UDI as an integration part towards global harmonization specially for European companies as well, this is an essential takeaway for the companies selling in the European market.

Medical devices makers were not the only party being unconvinced with the FDA initiative of UDI enforcement; many healthcare providers were also showing their concern and doubts that it will be challenging in terms of technicalities as well as financially incompatible.

Important Learning for Companies Selling devices in Europe

UDI implementation had the prospect to counterbalance much of the investment it takes. The healthcare industry needed for long a method to perfectly recognize medical devices to enhance procurement and inventory control, empower patient safety, and boost billing accuracy to minimize deception.


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