The medical device manufacturing industry is currently facing a period of regulatory reform unlike anything it’s seen before. The European Union is ground zero for the development of new regulations dictating how data produced and stored by medical devices is managed, preserved and disseminated, among other responsibilities.
At the center of this sea change is the EU’s Medical Device Regulation, which went into effect on May 25, 2017. The set of rules and guidelines established a three-year grace period for medical device regulations to make any necessary changes in order to comply with these new data standards. Even with an extension pushing the deadline to May 26, 2021 due to COVID-19, time is quickly running out to bring products and systems in line with MDR. Follow these steps to be adequately prepared once that window closes:
Conduct an internal review (if you haven’t already)
Hopefully at this stage in the game, your organization has already run a comprehensive audit to identify compliance gaps and determine what changes need to be made. If not, don’t worry, you still have some time to get things underway.
An important point to consider is that there is no grandfather clause built into MDR. It applies to both new and legacy products. However, devices lawfully placed on the market pursuant to MDD/AIMDD prior to May 26, 2021 may continue to be made available on the market until May 27, 2025.
Other areas to focus on include creating and preserving accurate documentation for every device, verifying clinical evidence and updating product labels. Medical device manufacturers may find that the costs to comply with these stricter requirements for older devices may not be worth the amount of revenue such devices are expected to generate. In those cases, their analysis may reveal that the better course of action is to retire those legacy medical devices and focus their energy on developing more sophisticated product lines that comply with MDR.
Make internal product data systems compatible with EUDAMED
One of the core requirements facing medical device manufacturers that hope to continue doing business in European markets is submitting a wide variety of device data to the European Database on Medical Devices (EUDAMED). That information includes unique device identification numbers, product data and clinical evidence data. The EUDAMED will function as a centralized repository of information from which various entities, such as Notified Bodies, regulators, healthcare companies and consumers can all access and view medical device data.
Medical device manufacturers will need to update or replace their product data management platforms so they are compatible with EUDAMED’s data standards. At the same time, companies need to be mindful about similar regulations taking shape in other international markets. If they hope to continue selling their wares in those regions as well as the EU, medical device manufacturers need to implement a product data management solution that is both flexible and scalable and can facilitate operations in various markets.
Work with an experienced implementation partner for MDR preparation
Depending on the current state of their existing product management systems, manufacturers could have their work cut for them. Ripping and replacing an entire platform is a major undertaking — although a wholly necessary one, given the stakes at play.
Company leaders shouldn’t feel as if they need to take on such an extensive and complex project on their own. Working with an experienced implementation partner that has successfully carried out numerous similar projects in the past will help clear any obstacles and potential disruptions.
Even though the MDR deadline has been pushed back to 2021, why not get a jumpstart and partner with an organization like Inspirage to streamline and accelerate implementation. Our experience and expertise can deliver guaranteed results in a short project window.
Inspirage’s Product Lifecycle Management solutions expand upon the core functionality of leading product management platforms like Oracle PLM Cloud. While those software suites are typically industry-agnostic, Inspirage’s implementations can be tailored to the specific requirements of medical device manufacturing, giving you a PLM solution that comprehensively addresses your regulatory demands.
MDR’s deadline is still right around the corner, so don’t wait longer to bring your systems into compliance. Contact Inspirage today for more information and assistance.
