New EU IVD and medical device regulations to be adopted in 2016

9 November, 2015, by ClinCaptureTeam

European union officials are planning to impose stricter regulations on all companies in the medical devices field, thus changing Europe’s reputation as a destination with favorable regulatory policies.

The revisions are expected to be adopted in the first half of 2016 and implemented in 2019, and would affect existent medical device and in vitro diagnostic device regulations.

According to a report from BSI Group, both medical device categories would be subject to a new supply chain structure, as well as a new risk classification system, and tougher testing and certification standards.

Also among the proposed changes is the addition of cosmetic implants, contact lenses and invasive laser equipment to the regulated med devices list.

BSI Group points out that in the in vitro diagnostic space, the number of devices requiring a notified body certification would go up to almost 90% compared to only about 20% now.

In addition, the new provisions prohibit grandfathering of medical devices already on the market so all new and existent products must comply within a given timeline once the new regulations are written into law.

Coming up next, Clinovo will feature a short blog series discussing the impact of these new regulations on medical device companies with advice from a Q&A expert on ensuring compliance.

The U.S. might be next on the list to update its current drug and medical device approval process. Right now, it takes between 12 and 15 years to get from discovery to market. According to Wireless-Life Sciences Alliance (WLSA), five out of 5,000 drug compounds make it to human testing and only one out of these five is approved to be sold on the market. In other words, the process has not kept up to speed with advances in technology, medical knowledge and patient behavior.

The WLSA has proposed a redesigned approval process pictured in the info graphic below, including suggested improvements to the regulation of drugs, medical devices and health IT.