The arrival of new regulations in the EU has been one of the hottest topics in the medical device space over the past several years. They were first proposed in 2012 and are finally here in 2017. The new regulations were aimed at three main goals:
- Improve the quality, safety and reliability of medical devices
- Strengthen transparency of information for consumers
- Enhance vigilance and market surveillance
Despite the concern whenever new regulations are established, companies and governing bodies will have some time to make a transition: three years after publication for the regulation on medical devices and five years after publication for the regulation on in vitro diagnostics.
When it comes to high risk devices such as implants, joint replacements and insulin pumps, we will see stricter control. Gaps in oversight had previously led to several medical device scandals, most notably in hundreds of uncertified hip implants being placed. An expert panel in the EU will review all devices now before they go on the market, similar to current practice the U.S. with the FDA. Clinical trials in the EU will get more scrutiny as well. Next, Notified Bodies (private entities) who are used by companies to gain approval to market a device, will fall under much tighter controls. Many products which were previously unregulated in the EU, such as colored, non-prescription contact lenses, will now be regulated and a new system to classify risk is being implemented, much like the FDA. This classification system will cover diagnostics as well. Dramatic changes may occur in terms of go to market strategies employed by many device companies that previously would model a Europe commercialization pathway before the U.S.
Information on devices and implants will become widely available on databases, much like is done by the FDA, and adverse event reporting will also be public and widely available. Companies will be required to track performance data on products, once commercialized, and the EU will review this data. These new reporting requirements will result in significant expenses to companies who are commercializing devices in the EU.
The biggest impact could be in clinical investigations of devices. Previously, many companies pursued CE Marks in the EU (Class I, IIa and IIb) because they were able to obtain a CE Mark with minimal to no clinical investigation. This would allow a product to get to market sooner and with less cost in the EU and other countries that recognized the CE Mark. With the new regulations, fewer products will be able to meet the requirements without a clinical study, and these studies will involve larger cohorts than in the past. Also, particular attention will need to be given to new materials being used, target populations and recognized risks. Finally, Notified Bodies will encourage increased surveillance including unannounced audits.
All these changes and more will require companies and to reevaluate their strategies for new products and new markets, while also reviewing and updating marketed products. The greatest impact will be felt in high risk device areas such as implants; however, the trickle-down effect will also will have repercussions with lesser risk devices such as delivery systems and visualization technologies. All of this may take away the advantage companies have historically sought to gain by commercializing first in the EU, or at least make it more complex.
Locust Walk’s medical technology team has a global presence and active involvement with clients in Europe and Japan, which makes us ideally suited to help companies understand potential markets and regulatory implications through quantitative and qualitative Commercial Assessments. We also are able to successfully manage complex multi-track transaction processes to find the best strategic partners and/or investors in parallel. Please contact us if you would like to discuss how we can support your company: stewart@locustwalk.com
Written by Stewart Davis, M.D.