The European Commission recently announced a two-year delay for the launch of the new version of the European Database on Medical Devices (EUDAMED) being built to support the European Medical Device Regulation (MDR) including the module that will hold unique device identifiers (UDIs) and other required data on medical devices. The delayed launch, now scheduled for May 2022, effectively gives medical device manufacturers an additional two years before they must submit the UDI-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 findings 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 UDI 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 UDI 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 UDIs and post market research. Even though the UDI 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:
- Lack of timely guidance from the European Commission
- Lack of internal resources (especially IT)
Complying with the MDR is a significant investment, with more than one-third of manufacturers estimating they will spend more than $5 million to do so.
As with the Food and Drug Administration (FDA) UDI 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 MDR specifically 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 benefits, of the device when used as intended by the manufacturer.” This data is to be collected throughout the lifecycle of a device in order to generate longitudinal evidence on performance.
While not specifically discussed in the regulation, the generation of such data necessitates the ability to capture UDIs on the specific devices being used in clinical practice. This is something providers in the U.S. have been grappling with as UDIs have become more prevalent and as EHR vendors and providers, respectively, seek to meet requirements to capture and store UDIs for implantable devices 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 UDI data have been addressed by the AHRMM Learning UDI Community (LUC) and reported in past issues of Standard Practices (See the September 2019 issue on Making UDI 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 implantable devices have uncovered challenges with the implant flags associated with FDA product classification codes (procodes) in the FDA’s Global UDI Database (GUDID). Each procode is associated with an implant flag (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 implantable 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 LUC work group on high risk implants determined that, while not perfect, use of the Global Medical Device Nomenclature (GMDN) code assigned to a UDI device identifier in the GUDID 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 reflect 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 Device Nomenclature (EMDN) based on the Italian classification system (CND). Meanwhile, the World Health Organization (WHO) is developing its own system to make classification more accessible in third world countries. This further underscores the need for understanding the different purposes and the relationships between different classification systems. (See November 2019 issue of Standard Practices on device classification.)
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.
