STANDARD PRACTICES


European UDI: Start delayed but the race is on


by Karen Conway, Vice President, Healthcare Value, GHX T


he European Commission recently announced a two-year delay for the launch of the new version of theEuropean Database on Medical Devices (EUDAMED) being built to


support the European Medical Device Regulation (MDR) including the module that will hold unique device identifi ers (UIs) and other required data on medical devices. The delayed launch, now sched- uled for May 2022, effectively gives medical device manufacturers an additional two years before they must submit the UI-required data to EUDAMED. As a result, both medical device and in-vitro device manufacturers will have 18 months after the launch date to submit the required data on all of their products regardless of class. That may seem like a long time, but based on the fi ndings of a recent survey, medical device manufacturers should not mistake the delayed start as a reason to turn their attention away from what it will take to comply with the MDR. Hospitals and healthcare systems in the European Union should also be thinking now about how they will comply with MDR requirements to capture data on implantable devices used in patient care in electronic health records (EHRs). Additional requirements in the MDR for manufacturers to continually monitor and report on product performance once devices are on the market will necessitate closer collaboration between providers and suppliers to ensure UI capture and use. In this issue of Standard Practices we will explore why the global medical device ecosystem should learn and support one another on the continuing UI journey.


Why the delay? To support the MDR, the Commission is building a new version of EUDAMED to provide better visibility and coordination of data related to medical devices. The new version will contain multiple modules, including those for UIs and post market research. Even though the UI module is ready, the Commission determined that all modules must be ready and audited before Eudamed can become operational.


Manufacturers not ready for MDR The news of the delay was welcomed by many manufacturers who are not prepared for MDR compliance. A new study by KPMG and the Regulatory Affairs Professionals Society (RAPS) found that nearly half of manufacturers have not yet developed a strategy for publishing data to EUDAMED. The respondents state two primary reasons for their unreadiness:  ack of timely guidance from the European Commission  ack of internal resources (especially IT) Complying with the M is a signifi cant investment, with more than one-third of manufacturers estimating they will spend more than $5 million to do so. As with the ood and rug Administration (A) UI rule,


compliance with the MDR will require a continual effort, although the requirements are even more onerous in Europe. More than two- thirds of survey respondents also reported not having a strategy for ongoing compliance.


Manufacturer and provider collaboration essential The M specifi cally states that manufacturers must “continuously generate, collect, analyse, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefi ts, of the device when used as intended by the manu- facturer.” This data is to be collected throughout the lifecycle of a device in order to generate longitudinal evidence on performance. While not specifi cally discussed in the regulation, the generation


of such data necessitates the ability to capture UIs on the specifi c devices being used in clinical practice. This is something providers in the U.S. have been grappling with as UIs have become more prevalent and as EHR vendors and providers, respectively, seek to meet requirements to capture and store UIs for implantable de- vices in EHRs and to share such data as part of the U.S. Core Data Set (proposed new name for the Common Clinical Data Set). Some of the challenges with capturing UI data have been addressed by the AHMM earning UI Community (UC) and reported in past issues of Standard Practices (See the September 2019 issue on Mak- ing UI Work). These range from challenges with barcode scanning to being able to effectively identify which products are implants. Recently, some U.S. hospitals attempting to create a list of im- plantable devices have uncovered challenges with the implant  ags associated with A product classifi cation codes (procodes) in the A’s lobal UI atabase (UI). Each procode is associated with an implant  ag (yes or no) and a query of the procodes with the ‘yes’ value returns a list that includes both implants and other devices, e.g., implantable staples and the stapler itself. This is even more challenging for products such as a stapler preloaded with im- plantable staples. Use of the United Nations Standard Products and Services Code (UNSPSC), which was designed more for e-commerce and spend analysis, has similar problems. The UC work group on high risk implants determined that, while not perfect, use of the Global Medical Device Nomenclature (MN) code assigned to a UI device identifi er in the UI and their associated GMDN implantable collective codes delivered the best results. Unlike procodes, manufacturers have more discretion in assigning GMDN codes. The work group recommends providers and manufacturers collaborate to help ensure the codes accurately re ect the most frequent use of products.


The European Commission has chosen not to use GMDN for Eudamed and instead plans to create a new European Medical evice Nomenclature (EMN) based on the Italian classifi cation system (CND). Meanwhile, the World Health Organization (WHO) is developing its own system to make classifi cation more accessible in third world countries. This further underscores the need for un- derstanding the different purposes and the relationships between different classifi cation systems. (See November 2019 issue of Stan- dard Practices on device classifi cation.)


None of this is easy, but all of it is vital to ensuring effective


management of medical devices around the world and requires communication and collaboration across the global medical device ecosystem. HPN


46 December 2019 • HEALTHCARE PURCHASING NEWS • hpnonline.com


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