Question

You are a new investigator planning your first medical device clinical investigation in Europe. At a minimum, you should _________.

1) Obtain ethical approval from an ethics committee
2) Conduct a literature review to gather background information
3) Develop a study protocol outlining the objectives and methods
4) Obtain informed consent from study participants
5) Submit an application to the regulatory authority for approval

Answer 1

To conduct a medical device clinical investigation in Europe, you should obtain ethical approval, conduct a literature review, develop a study protocol, obtain informed consent, and submit an application for approval.

Step-by-step explanation:

As a new investigator planning a medical device clinical investigation in Europe, there are several key steps you should take. First, obtain ethical approval from an ethics committee to ensure that your study meets ethical standards. Next, conduct a literature review to gather background information on the topic you are studying. Then, develop a study protocol that outlines the objectives and methods of your investigation. Additionally, it is important to obtain informed consent from study participants and submit an application to the regulatory authority for approval.