Medical device manufacturers face global economic challenges in an ever-changing regulatory environment. These changes come in the form of more stringent and complex regulations, higher patient expectations and commercial pressures. As the regulatory profession continues to grow in importance and prominence, regulatory professionals have become key contributors to a company’s ability to devise successful business strategies and execute these strategies effectively. Therefore, they need to build robust regulatory expertise by continuously sharpening, maintaining and expanding their skills, knowledge and understanding of relevant and applicable regulations and emerging technologies.
This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product lifecycle. You will gain a strong foundation in the key elements of the EU directives governing medical devices, including the Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and In Vitro Diagnostic Devices Directive (IVDD), and the 2007/47/EC amendments to the AIMDD and MDD. Examine how devices are classified and the effect classification has on labeling, registration, marketing and postmarketing requirements.