With the imminent publication of the new Medical Device Regulations (MDR) taking shape in Europe, Unique Device Identification (UDI) is quickly becoming a requirement for all medical devices. Manufacturers should take full advantage of becoming UDI compliant as quickly as possible. In fact, manufacturers who are on top of launching an all-encompassing UDI implementation plan will garner the best rewards for their business.
Current state of UDI and Serialisation including diagnostic challenges, existing inventory and exemptions, submissions, device classes and redactions
The benefits of fast adoption and prompt compliance
The consequences of non-compliance
Mr. Cottrell comments: “Despite the upfront costs required to implement UDI, when implemented properly, manufacturers will be well positioned to reap long-term benefits, including influencing their bottom line, particularly if they ensure they are meeting compliance standards early on in the implementation process. The risk of lost sales and a damaged reputation isn’t worth the risk of delayed compliance.” Ms. Tomes remarks: “Medical device manufacturers who understand that UDI is more than just a regulatory compliance process with deadlines, but rather, an expansive measure toward global regulatory harmonization, will benefit the most from implementing the specific requirements.”