Types of research and regulatory aspects

What are the differences in formal requirements between clinical trials and observational studies? How to Submit a Clinical Trial Application in CTIS? Can a CRO assist in preparing and submitting a clinical trial application in the CTIS system? I’m not sure whether my project qualifies as a clinical trial, a medical experiment, or an observational study. Are approvals from the Bioethics Committee and URPL always required? Do you assist with product or device registration? Can a CRO help prepare documentation for the Bioethics Committee? Does the company have experience with medical device studies under MDR?