As economic belts tighten around the world the medical device industry is one of the hardesthit, as one of the most competitive industries. While competition has increased, medical device recalls around the world have also increased in recent years. European authorities recalled 434 devices in 2008, 611 devices in 2009, and 748 devices in 2010.
The technical file is the key to a medical device’s certification for CE marking because it contains the most important information about the device, how it works, how it is manufactured, and how it meets the applicable regulatory requirements.
Companies often seek to rebrand existing medical devices and sell them under their own name. This process is called Own Brand Labeling and offers faster market entry for companies wishing to build and complete their product portfolio compared to developing a new product.