Estudios Clínicos y Preclínicos​ - Inglés

In order to carry out clinical research with medical devices in accordance with current legislation (REGULATION (EU) 2017/745, R.D. 1090/2015) at the Hospital Clínico San Carlos, it will be a requirement to process the registration, obtain authorisation from the competent authorities, and sign a contract with the Research Foundation.

  The deadline for submission is linked to the calendar of IECm meetings.  Research involving medical devices shall be submitted at least five working days before the date of the selected assessment meeting. Check the current calendar of meetings here.

Formalities:​​

• Obtaining the document of suitability of the installations (if applicable). See the documentary requirements for the processing of the suitability of installations here.​
• Application for registration with a favourable opinion from another IECm. See the documentary requirements for the registration process here.​
• Application for evaluation of research involving medical devices by the IECm of HCSC. See the documentary requirements for validation and assessment here.​
• Signing of the contract with the Biomedical Research Foundation (Fundación para la Investigación Biomédica) of the HCSC and payment of the corresponding fees. See the requirements for contract processing and associated fees here.​
• Download templates here.​

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