Prompt Adoption of UDI Needed in Europe to Achieve Seamless Compliance
Want to listen to this article for FREE?
Complete the form below to unlock access to ALL audio articles.
Read time: 1 minute
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.
Even though the final details of UDI in Europe are unconfirmed, manufacturers who have already complied or are in the process of implementing UDI for the USA and the UK NHS, stand to gain significant benefits from continued early compliance – improved inventory control, potential increased sales and more time to identify and troubleshoot product issues.
UDI is not new; looking at the implementation of UDI in the USA and the UK NHS, highlights significant lessons which European manufacturers can learn in order to be prepared for the new requirements for UDI in the EU. In order to help manufacturers stay compliant and understand what is required, Maetrics, a leading international consulting firm focusing on providing life science companies with deep quality, compliance and regulatory solutions, has published a free whitepaper that is available to download here
The free must read guide, co-authored by Steve Cottrell, President at Maetrics and Madris Tomes, Founder and CEO of Device Events, focuses on the implementation of UDI in the USA and the lessons that can be learned from the experience in readiness to prepare for UDI introduction across Europe. The guide looks in particular at:
A detailed overview of UDI in the USA
The varying expectations of UDI (Federal perspective, manufacturers interpretation and a healthcare perspective)
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.”
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.”
