Currently there are 60 notified bodies left, and 40 will likely be redesignated under the future Medical Device and IVD Regulations. This is because some organizations may decide that the cost of meeting the heightened new regulatory demands outweigh the potential economic benefits for their organizations.
To get a quick overview of the Medtech Regulatory Approvals, download your complimentary infographic.
Get a clear perspective of the following:
• How this year’s performance of the FDA compares with that of recent years
• The number of 2016 US original PMAs and Panel-Track supplements
• The number of 2016 US PMA supplements
• The number of 2016 US 510(k) clearances
• How many approvals there have been in Europe
• How many non-approvals since July
• 2015’s total approvals from global regulatory agencies
• July 2016 non-US approvals, by category
• The new Medical Device Regulation and its anticipated impact