Halfway to the New European Medical Device Regulation, U.S. Manufacturers Feel the Pinch

The regulators are coming! The regulators are coming! In the swirling waters of the global economy, it can be hard to keep up with every new development. However, this October marks an important regulatory milestone that should not pass by unnoticed. While the reference at the top of this article may be a little misplaced (thanks to Brexit), please allow the proverbial Paul Revere to direct your attention to the following: We are now halfway through the three-year transition period between the European Union’s old directive for regulating medical devices, and the new Medical Device Regulation. The new directive goes into full effect in May of 2020. Of course, this still leaves about a year and a half for U.S. medical device manufacturers to become fully compliant. But, due to the fact that previously approved devices will need to be re-certified (the “no-grandfathering” rule), and that Britain’s exit from the European Union may end up reducing the total number of notified bodies that can certify devices, the clock is most definitely ticking. So why does this matter? Readers need only refer to the slew of GDPR emails that hit their inbox this past April to see a prime example of how European regulations can affect American companies. Representing nearly 25% of the global medical device market, the European Union has a lot of leverage when it comes to setting the rules for manufacturers. And, as compliance ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news