Staying on Top of New Regulations and Legislation

By January 9, 2019 No Comments

The medical device industry is poised to undergo some big changes in 2019, and many of these center around new legislation and regulations. Organizations would do well to stay a step ahead of the curve in terms of these changes as failing to do so could result in the loss of their license to operate. It should also be noted that while some of these changes occur in Europe, companies that sell or manufacture products there must comply.


European Union Medical Device Regulation (EU MDR)


We briefly touched upon the EU MDR in our list of 2019 predictions, but it’s an important measure that bears repeating. European regulation of the medical device industry has been fairly dormant since the 1990s, but this is about to change in light of some recent incidents – specifically the 2010 hip replacement recalls and the 2012 breast implant crisis. The new measures will include guidelines such as:


  • Greater transparency in terms of patient risks and benefits
  • More medical devices to be regulated
  • Safety and performance assessments of devices prior to sales
  • Clearer rules on simplified trading between members of the EU
  • Increased authority of “Notified Bodies,” and increased scrutiny on them


Companies will have until May of 2020 to comply with these new measures and should be aware that all current devices must be compliant as well.



In Vitro Diagnostic Regulation (IVDR)


The new regulation will have a significant impact on the industry because of all the new developments, since the current directive was written in the 1990s. Now products like lab-developed tests and research-only applications will be subject to regulation. The new rule-based classification system will increase the practicality of regulation, but it will also require far more in vitro device manufacturers to have Notified Body certification – potentially up to 90 percent.


The transition period ends in May of 2022, but manufacturers would be wise to begin their shift to compliance sooner than later.


Modernization of the FDA 510(k) Program

Not all recent legislative changes are causes for concern. In November of 2018, the Food and Drug Administration announced they would be changing their 510(k) clearance pathway to keep up with the rapid speed and evolving complexity of medical technologies. They’re referring to the new approach as the “Safety and Performance Based Pathway.” According to the FDA, “new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.” It’s very likely this new approach will help expedite the regulatory clearance process and get beneficial technologies into the hands of patients and consumers faster than ever before.


These are but a few of the new changes that will surely affect the industry now and in the near future. Stay tuned to our blog for the latest information and insights.