Introduction
The European Union Medical Device Regulation (MDR) is set to significantly raise the bar for medtech authorizations in the region. Once the MDR transition period ends in 2020, more medical devices will need to undergo clinical trials before being sold in the EU, forcing companies to trthink established market-entry strategies that use the region as a springboard for global launches.
Throughout the modern history of the medical device industry the EU has offered a truncated path to market to companies. Whereas the US Food and Drug Administration (FDA) demanded extensive data -- including results of studies in humans -- to approve or clear many devices for sale, authorities in the EU often permitted manufacturers with little more than a quality management system to market techonologies.
The presence of a major market that allowed the sale of medical devices on the strength of limited data resulted in the emergence of a well-trodden global commercialization strategy. The countless companies that followed this pathway first sought to secure a CE mark, the clearance needed to sell a device in the EU. CE marks are awarded by notified bodies, independent businesses designated by an EU country to perform premarket conformity assessments of certain products.
After securing a CE mark, a company can begin making commercial sales in the EU while working to bring its product to other markets. The value placed on the CE mark by regulators in markets such as Australia and New Zealand enabled companies to quickly expand globally after receiving clearance to enter the EU. As such, a CE mark not only gave companies access to a major market, it also served as a springboard for a rolling global commercialization push.
Some device companies never expanded beyond the EU and other easy-to-access markets, figuring that the potential payoffs were too small to justify the risk and investment needed to access other territories. Other companies used sales made in the EU to fund clinical trials designed to unlock markets with more rigorous regulatory requirements, most notably the US.
The US offers an abbreviated route to market to developers of devices that are similar to existing products -- a 510(k) premarket submission to the FDA -- but even that pathway is long and expensive compared with the EU process. A survey of 204 US medical device manufacturers found it took seven months, on average, to go from first communication to the receipt of a CE mark. In the US, the same process took 31 months. The gap is even wider for novel devices that follow the more rigorous premarket approval pathway.
These divergent timelines, and their effect on the cost of getting a device to market, mean the EU is the first region targeted by many companies. One analysis of novel devices cleared for sale in the EU and US found 63% of products received a CE mark before being made available in North America.
