The proposal submitted to the European Parliament would involve a centralized process with standards and requirements much closer to those of the U.S. FDA.
DMN: How will this impact both the European and U.S. medical device industries?
PT: Over the past several years, particularly after the FDA 510k process became more onerous and lengthy, development and early commercialization stage companies based in the U.S., Europe and other countries leveraged the relatively easier CE mark process to more quickly get to market (starting in Europe). This helped them to start generating sales and cash flow to help sustain themselves and fund later U.S. development efforts via the FDA regulatory process. Through this process, companies also generated some valuable clinical and market data, some of which could later be used in their development efforts for the U.S. market.
The impact would apply to both European and U.S. medical device industries (as well as those in other countries), and could be dramatic. It would raise the bar for medical devices to be approved for the EU market. As a result, companies may look first to other parts of the world that may have easier regulatory requirements in order to start generating revenues, such as Brazil and other parts of South America, Eastern Europe, or some Asian countries.
To some degree, a tougher EU process could stifle or filter out some innovation. It is also likely to force a number of companies to sell out to, or partner with, large medical device companies earlier on, and lead to a potential increase in M&A and strategic partnership activity.
Finally, European clinical research organizations (CROs) and other companies and consultants that provide regulatory assistance to medical device companies seeking approval in the EU market are likely to benefit because companies will need more help and advice. On the flip side, some European CROs might see some of their prospective clients go to other countries to do their first trials.
DMN: What kinds of medical device companies will be affected the most?
PT: Certainly most affected will be companies with "Class II" devices - devices that have lower risks, generally those that are non- or minimally-invasive - that have not required large, lengthy clinical trials or other stringent requirements. It will also impact development-stage and early commercialization-stage companies that have depended on a faster, easier CE process to begin generating revenues in Europe to help funds development efforts in the U.S. and other countries.
