The Medical Device Coordination Group has released the “MDCG 2021-6 Questions & Answers regarding Clinical Investigations”.

 The MDCG has been more busy recently, publishing guidance documents to create more clarity and answer the industry’s questions. This latest document adds to this list, answering key questions like "What is the difference between the performance, clinical performance and clinical benefit?" and "What are the general differences and improvements related to clinical investigations under the new Regulation as compared to the Directives?".

 In total 26 questions are answered, covering topics such as:

->  General Questions – What is a clinical investigation, what is considered burdensome or invasive

->  Modifications to Clinical Investigations – How are they defined, can a sponsor submit a modification notification

->  Timeline considerations – What date is the start and end of a clinical investigation, when does the sponsor have to submit results

->  Clinical investigation reports – What is the content?

->  Transition Period Arrangements – EUDAMED is not ready by May 2021, how can the sponsor follow the MDR and more!

🔍 Original PDF: https://bit.ly/2SFgse8