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Clinical investigations of Medical Devices for human use (hereinafter referred to as MD) assess the safety and clinical performance and evaluate the suitability of an MD for the purposes and the populations(s) for which it is intended. With respect to the wide diversity of medical devices and their associated risks, different provisions may apply and must be complied with when planning and undertaking a clinical investigation of the MD in question. The comprehensive information compiled in this section takes into account the different types, risk classifications (Class I, IIa, IIb, III) and authorisation status (CE-marked, Non-CE-marked, CE-marked but used outside label) and encompasses the applicable national legislation and regulatory requirements on procedure and contents of a clinical investigation plan, submission to Competent Authorities and Ethics Committees, reporting obligations, safety measures as well as specific provisions regarding protection of vulnerable groups, informed consent, insurance, and data protection. This study type also applies to combination products that are – on the basis of their principal mode of action - regulated as medical devices.

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Clinical trials/studies with medicines are investigations in humans intended to discover, test or verify the effects of potential treatments with one or more investigational medicinal products (IMP), to identify any side effects, to evaluate the safety, pharmacokinetics or efficacy and/or to confirm the effectiveness of the IMP in question. The information covered in this section also includes relevant details of clinical trials of advanced therapy medicinal products (ATMP), such as gene therapy medicinal products and somatic cell therapy medicinal products. It further applies to combination products that are – based on their principal mode of action - regulated as medicinal products. Searching this study type will provide information about applicable national legislation and regulatory requirements on procedure and contents of a clinical study plan, submission to Competent Authorities and Ethics Committees, reporting obligations, safety measures as well as specific provisions regarding protection of vulnerable groups, informed consent, insurance, and data protection. A particular focus is given to interventional studies and its relevant aspects.

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In the field of human nutrition studies, a considerable body of research is being conducted across Europe, however, a harmonized regulatory framework with established operational principles and standards for high-quality design and conduct of human studies is not available (unless nutrition is considered as a medicinal product). There is some guidance for European researcher provided by international ethical guidelines and declarations. Given the heterogeneity of human nutrition studies in terms of populations, outcomes, designs, methodologies and interventions, this study type is further subdivided into sub-sections such as non-interventional (observational) studies and interventional studies with particular focus on different study populations (patients, healthy volunteers, vulnerable populations). The comprehensive information compiled in these sections is mainly based on commonly accepted procedures in the respective European countries, but also covers eventual applicable national legislation and regulatory requirements on procedure and contents of a study plan, submission to Ethics Committees and Competent Authorities, reporting obligations, safety measures as well as specific provisions regarding protection of vulnerable groups, informed consent, insurance, and data protection.

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