Prompt adoption of UDI needed in Europe to achieve seamless compliance

Maetrics, an international consulting firm which focuses on providing life science companies with compliance and regulatory solutions, reveals key lessons for medical device manufacturers when it comes to preparing for unique device identification.

With the imminent publication of the new Medical Device Regulation (MDR) taking shape in Europe, unique device identification (UDI) is quickly becoming a requirement for all medical devices.

The aim of the new MDR is to strengthen the rules on placing devices on the market and tightening surveillance once they are available, ensuring that medical devices are safe and high quality.

Manufacturers have been encouraged by Maetrics to take full advantage of becoming UDI compliant as quickly as possible, adding that manufacturers who are on top of launching an all-encompassing UDI implementation plan will garner the best rewards for their business.

The final details of UDI in Europe are unconfirmed but manufacturers who have already complied or are in the process of implementing UDI for the US 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.

Steve Cottrell, president at Maetrics, commented: “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.”

Madris Tomes, founder and chief executive officer of Device Events, remarked: “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.”

The guide, co-authored Cottrell and Tome, focuses on the implementation of UDI in the US and the UK NHS and 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, has published a free whitepaper.

It 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), the 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 and the consequences of non-compliance