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Clinical trials of medical devices

🔴Clinical trials of medical devices

Clinical trials shall be designed, authorised, conducted, recorded and used as part of the clinical evaluation for conformity assessment for one or more of the following purposes

📍To confirm and verify that the device is designed, manufactured and packaged to meet the conditions of use of the medical device and that it performs as claimed by the manufacturer;

📍To confirm and verify the clinical benefit of the device as claimed by the manufacturer;

📍To establish and verify the clinical safety of the device and to identify any adverse reactions that occur under normal conditions of use of the device and to assess whether they represent an acceptable risk in relation to the benefits the device is intended to provide.

A clinical trials may be conducted if the cumulative conditions are met:

📍The trial is subject to an authorisation granted by the Member State in which the trial is to be conducted;

📍The bioethics committee has not given an unfavourable opinion on the trial in question;

📍The sponsor or contact person is established or resident in the Union;

Particularly vulnerable populations and participants are adequately protected;

The anticipated benefit to the participants or to public health justifies the foreseeable risks and discomforts, which are continuously monitored;

📍The participant or his/her legal representative has given informed consent;

📍The participant or his/her legal representative has been provided with the contact details of an organisation from which he/she can obtain further information if necessary;

📍The participant's right to physical and mental integrity, to privacy and to the protection of his/her personal data is respected;

📍The study is designed to cause the least possible pain, discomfort, anxiety, and foreseeable risk to the participant, and both the threshold of risk and the level of burden on the participant are detailed in the protocol and are continuously monitored;

📍The medical care of participants is the responsibility of an appropriately qualified physician or, where appropriate, a qualified dentist or other person authorised by law to provide appropriate care to patients in the trial setting;

📍No undue influence, including influence of a financial nature, is exerted on the participant or the participant's legal representative to induce participation in the trial;

📍The investigational product meets the applicable general safety and performance requirements, except for the issues covered by the trial, and in respect of those issues, all precautions have been taken to protect the health and safety of the trial subjects;

📍The requirements of Annex XV of the MDD are met.

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