The goal of filing a submission documentation to an authority or a notified body is obtaining a registration of a medical device. A successful registration is needed before a device can be placed on a market. After the submission, manufacturers often receive an additional information request or deficiency report, which leads to prolonging of the application process. What are the hurdles? Countries in which medical device regulations exist mostly require a so-called "submission documentation for registration". This is required before a manufacturer can place his medical device on the market. The submission documentation contains information of the medical device defined in the respective regulations and the responsible authority will review. After the documentation has been reviewed and approved by the competent authority, the manufacturer has the permission to distribute his device in the respective market. What might sound like a simple and logic process looks completely different in reality. In many cases, the manufacturer receives an additional information request by a deficiency letter, as the information provided is not sufficient. This results in a prolonged submission process which was not planned or anticipated by the manufacturer and thus, in a delayed market entry. So what are the hurdles? Usually, the deficiencies are caused in the lack of information within the submission documentation. In order to obtain a successful registration, it is substantial that the submission documentation is complete and fulfills all the requirements the authority asks for. Therefore, soundness and comprehensibility are the keys.
Our experts at knoell can help you to bring your documentation to required level of quality by analytical thoroughness and long-standing expertise in this field.