Your 2019 ‘Regulatory Issues to Watch’ List

In 2018, one of the most prominent themes for the medical device industry had to be change. The year marked a continued transition for a number of regulatory initiatives as well as the emergence of several new challenges. In spite of how serious some of the upcoming changes will be for OEMs, many are lagging behind in preparing appropriately for the transition (or at least that’s what I keep being told). With this in mind, I decided to take a moment to recap several major changes or potential shifts that will undoubtedly impact orthopedic device firms to be sure you keep these top of mind and are aware of key timelines.

MDR—the updated replacement to the MDD, the European regulatory standard that was rolled out in 1992—was arguably long overdue. The industry has since seen significant changes in disease states and chronic conditions, as well as the technologies available to help diagnose and treat them. While all medical devices that previously required a CE mark to reach the European market will need to be re-certified under the new MDR (by May 25, 2024), there are a number of technologies that will now apply for the regulatory clearance for the first time (primarily those tied to cosmetic procedures). While the May 26, 2020, deadline is still over a year away, preparation should be on the minds of orthopedic firms in 2019. This leads, however, to another change that will impact the regulatory landscape in the near future.

The U.K. leaving the European Union (EU) has a substantial impact on the transition to the MDR. Depending upon the ultimate outcome of Brexit (anticipated to take place at the end of March pending a reversal or delay of the separation), notified bodies (NB) in the U.K. would be unable to issue a CE mark for devices for the EU marketplace. With approximately 45 percent of all medical devices gaining access to the region via a U.K.-based NB, the sheer volume of devices requiring review could easily overwhelm the available firms able to grant a CE mark. As such, it’s critical that orthopedic device manufactures are aligned with an appropriate NB that can enable them to keep their products in Europe.

Meanwhile, on this side of the pond, the FDA is working on a number of changes to regulatory procedures that will undoubtedly mean new protocols for orthopedic devices being submitted for clearances or approvals. Most notable is the 510(k) modernization effort the agency announced near the end of last year. Since any revisions or alterations would be in the very early stages in 2019, it is highly unlikely orthopedic firms will need to revisit their submission process this year. Given how significant any regulatory change could be, however, it’s vital for companies to remain abreast of the discussions being held about the 510(k) pathway.

To add to the uncertainty associated with the 510(k), companies may wish to revisit this regulatory option regardless. In the January/February issue of MPO, Vicki Anastasi of ICON mentions the advantages a device manufacturer can realize by choosing the PMA pathway over the 510(k). In the column “A Primer for Manufacturers Adjusting to Value-Based Healthcare,” she stated, “…from the provider’s perspective, claiming a device is equivalent to an older device means its worth is no more than the older device. So, for truly innovative devices, manufacturers must consider the worth of investing in a PMA program that gathers detailed clinical evidence and cost impact information, and at the same time, give the innovative device an edge once it is available on the market.”

While the aforementioned changes could represent the potential for major shifts in the industry with regard to regulatory pathways, it still doesn’t reflect all the upcoming transitions. I didn’t even mention ISO 13485:2016 or MDSAP, nor did I discuss changes occurring in other regions of the world that have impacted the medical device industry, such as India.

Hopefully, you aren’t completely overwhelmed at the prospect of all these coming revisions to the regulatory landscape. It can be daunting, which can cause inaction at a company. That, however, would represent the worst case scenario for addressing these changes. Instead, ODT (and sister publication, MPO) will try to keep you appraised of important information regarding worldwide regulatory updates. Further, the ODT Forum is returning to Memphis this year (April 11) with sessions that will examine new technologies, highlight regulatory issues, and showcase executive insights on critical issues.

Further, I wanted to take a moment to highlight another fantastic information source that will be happening in the U.S. this year in Las Vegas during the annual AAOS meeting. While not centered on regulatory specifically, Ali Madani’s Implants tutorials (previously presented in Paris, France) is a must-attend for those involved in contract manufacturing within the orthopedic device industry, whether service provider or OEM. Check out more information on this fantastic opportunity at http://tutorials.implants-event.com/. 

Sean Fenske, Editor-in-Chief
[email protected]