We had a great turnout for the May 22nd webcast on “Navigating the Challenges of the Modernization and Expansion of EU Medical Device Regulations.”
When we asked participants to rank their anticipated risks as medical device regulations evolve, an overwhelming majority (80 percent) expressed at least a medium level of concern.
While there is broad consensus that these directives are outdated and often inconsistently interpreted by EU member states, the current system has two significant strengths.
- The relatively streamlined processes mean that devices are available in Europe an average of 43 months before they are marketed in the US.
- Comparisons of serious recalls of medical devices have found little difference between the EU and US despite significant differences in the approval/certification process.
Switching to a centralized system has the potential to drastically increase the time it takes to get a device to market in the EU, especially considering the amount of data that is likely to be required on higher-risk medical devices in the future. Conducting additional research does require time and money, although there does not appear to be an expectation for pharmaceutical-style trials involving large numbers of patients. Concerns about delays during the review and approval process may be more difficult to substantiate if the approving bodies establish (and adhere to) fixed timelines. If the EMA can review a new drug application in 270 days, then presumably any medical device could be adequately vetted in the same time period.
Nonetheless, although we advise adhering to the new guidelines as soon as you know what they are in case your trial faces setbacks, the reality is that the new regulations won’t likely come in to full effect until 2019. In a best-case scenario, the Parliament and Council will adopt drafts of the new directives and slowly begin implementing them starting in 2015. Therefore, device development programs nearing completion in 2013 should be able to proceed unhindered.
For more information on the future of medical device regulations, download the slides. To stay in-the-know about an upcoming ebook on EU medical device regulations, please leave your contact information in the comments section.