This article will detail the various steps you will need to take for an entire CE Certification cycle for your product. At CiteMed we focus on delivering the CER and accompanying Literature Reviews (the cornerstone of your submission) but believe in having knowledge of the larger submission process.
Your compliance requirements are determined by your product classification. Information on how to classify your product can be found online.
While nothing is needed for this phase in terms of physical deliverables, it’s important that you correctly classify your device before proceeding with the CER and Literature Reviews as your classification determines which current regulation applies to your submission (or lack of submission).
Now that you have your research and Technical file completed, you will enter the final stage of the process which involves making the actual submission.