Medical Device Regulation In The European Union
Aesthetics Biomedical Chief Regulatory Officer Tim Duggins and CEO MaryAnn Guerra traveled to Prague for important regulatory and industry updates on the European landscape. Here are some thoughts from Duggins on the importance of constant diligence in this area.
“There is a tidal wave of change coming in the way medical devices are regulated in the European Union. Some telling facts include this: today there are three directives numbering a total some 75 pages; in April 2017, there will be one regulation with more than 380 pages. Six months ago, there were 80+ European Notified Bodies (key agencies helping inspect and monitor medical devices); today there are less than 50, and soon that number will dwindle again as the notified bodies are simply unable to cope with the regulatory changes to the satisfaction of the EU member state’s health regulators,” says Duggins.”
In the existing directives there are only a small handful of defined regulatory terms; in April 2017, there will be 72 terms. The Essential Requirements (key safety requirements) are covered in eight pages; in April 2017, there will 30 to 35 pages of general safety and efficacy requirements. The reality – there are five times as many regulatory pages and less than half the number of notified bodies accredited then before. In short huge changes and few options for manufacturers. The EU commission recognizes that as many as 50 percent of the companies carrying the CE mark now will not be able to do so in April 2017 and the resulting turmoil is needed to gain the necessary safety improvements.
“ABM’s executive and regulatory teams were well represented at a meeting in Prague this week, where these changes were discussed for the first time. In fact, we had representation in both the medical and the cosmetic presentations. At its inception, ABM recognized that a fully internalized and well-resourced regulatory team would be key contributor to its growth. ABM had the foresight to begin implementing the required changes more than six months ago, and is well prepared so much so in fact many requirements have already been addressed,” says Duggins.
There will be no disruptions in ABM’s regulatory compliance; business as usual! The pursuit of skin perfection continues unabated!
Aesthetics Biomedical’s executive team and regulatory experts stay on top of requirements by participating in a host of national and international forums, standards writing efforts, advisory committees and by periodically meeting with regulatory agencies right around the world. We manage and implement change before it is mandatory to do so.
Aesthetics Biomedical is the “can-do” partner every company in this dynamic industry should have.
For more information on how Aesthetics Biomedical’s regulatory team can help you overcome barriers please send us a message or call us at 1.800.726.5029