Now that some of the hype in the US has died down following the election, it's time for us to turn our attention to some big news in Europe. Recently, the European Commission put forward a proposal to revamp the medical device directives in the region. This proposal was sped up following a number of controversies, including the PIP breast implant scandals, which put an uncomfortable focus on the twenty-year-old medical device directives.
There have been a number of accusations that the current directives weren?t doing a good enough job of ensuring the safety of patients. This may have partially just been due to confusion over the sheer number of legislative texts and rulings that have added various pieces to the directives over the years. The new directives are purported to consolidate these texts and roll them into one larger, simplified, strengthened medical device directive.
Key reform elements include strengthening oversight of assessment bodies in an effort to ensure greater uniformity across the EU, tightening clinical trial requirements, bolstering device monitoring and market surveillance, updating device classifications in line with more comprehensive health and safety requirements, and the creation of an enhanced Eudamed medical device database to increase transparency and manage greater registration requirements. The adoption target for these revisions is 2014, with implementation to begin the following year and continue through 2019.
There has been talk for awhile of the vast differences between approval times in Europe and the US, leading to the so-called innovation crisis in the US. In fact, the stringent FDA regulations have been recently brought up in a negative light at two important industry conferences in the US, the North American Spine Society (NASS) Annual Meeting and the Transcatheter Cardiovascular Therapeutics (TCT) conference. So it's not totally surprising that this European initiative has therefore run into some resistance?yes, the EU is worried about stifling innovation as well. But, patient safety can?t be ignored for the sake of innovation, and much of the industry realizes this and supports this stricter regulation.
So, as the FDA promises to shorten approval times and become more efficient, the European Commission is striving to be more stringent, no doubt lengthening approval times and increasing costs for manufacturers. Hopefully these initiatives will eventually lead both groups to a comfortable middle territory, where patient safety can be effectively balanced with efficiency and innovation.