Post-Market Medical Devices: Keeping Compliant in Europe
Thursday, August 27, 2015
Source: MDT Magazine
What needs to be done in order to keep CE mark approval in Europe for non-European manufacturers? Since gaining the approval is no doubt a long, complicated process, making sure that the approval is sustained is vital. Individual country requirements can vary and systems for vigilance and post-market surveillance must be in place for all classes of IVDs and medical devices before marketing a single device. In addition, any change made to a device after it has been placed on the market must be assessed by the manufacturer to determine the impact to safety and effectiveness of the product.