The medical device market is generally seen as an area with high growth potential and provides greater profit margins including significant positive benefits to the patients. As the medical device regulations and the guidance document are becoming stringent in the US, manufacturers of these types of products are now facing these conundrums along with a need for clarification on matters related to various drug and device provisions. The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices. The new changes in the regulations represent an important step forward in the growing philosophy of medical devices in Europe. Along with the regulatory challenges, there are various challenges faced during the innovation of such products. There are many factors that affect innovation including the patent aspects. In general, the key thing is that small firm face lots of difficulty compared to larger firm in bringing medical device in market. Thus, the proposed manuscript focuses on understanding the regulatory issues in various countries for ease of innovation and marketing authorization of medical devices.

The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices. The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices.