EUDAMED vs GUDID UDI Requirements
HyperClear is committed to helping clients streamline the supply chain and traceability of medical devices. In this blog post, we would like to explain the main differences in UDI requirements between EUDAMED (EU region) and GUDID (US). Please note that EUDAMED database is intended to collate and process information regarding devices on the market while GUDID solely serves as a repository of UDI information. We are only discussing UDI-related requirements in EUDAMED in this post.
Under EU MDR, Class I devices must have both device identifiers (DI) and product identifiers (PI). On the contrary, the FDA requires Class I devices to have only DI. DI is the static information which identifies company and product information (e.g. company name and address, product name and GMDN code and terms) and PI is the dynamic information which contains production and control information (e.g. lot/batch/serial data, expiration date, manufactured date).
In addition to the device identifier and product identifier, EU MDR requires a new identifier called basic UDI-DI. Unlike DI and PI, basic UDI-DI does not appear on product or packaging labeling. It serves as the main key for administrative records in certificates, decelerations of conformity, and technical documentation. Basic UDI-DI enlists all associated devices with the same intended purpose, risk class, and essential design and manufacturing characteristics (e.g. a certification has one basic UDI-DI which covers all spec of devices).
There are many rules being implemented on what devices can be exempted from the UDI requirements. However, under EU MDR, only individually packaged Class I and IIa single-use devices (SUDs) can be exempted from individual marking as long as the package containing these individual devices has a UDI (e.g. a box of disposable needles can fit into this exception). On the contrary, the FDA extended this exception to all classes but does not apply to implantable devices. Some other exemption examples are below:
Custom and investigational devices
Devices for retail or point of sales do not need the PI in AIDC (automatic identification and data capture) on the point of sales UDI label
Significant space constraints on the unit of use packaging
Place UDI on the next higher level of packaging
If limited space for both AIDC and HRI (human readable information) on label, only AIDC required
Unless intended for home care, then HRI on label and no AIDC
Please stay tuned with the blog for future HyperClear releases with additional features to support our clients not just meeting the regional UDI requirements, but also gaining visibility of device supply and movement through the supply and distribution chain, in turns improving visibility and management of adverse events, recalls, potential fraudulent activities, and post market surveillance purposes. We highly encourage all the manufacturers out there to start engaging HyperClear platforms today!