EU 2017/745 enforces all manufacturers must clinically evaluate a medical device before they apply with any Notified Body or placing it on the European market. To do so, the manufacturer has to collect and evaluate clinical data in order to investigate whether the medical device is safe and performing. However, if the clinical data are insufficient, manufacturer must conduct medical device clinical trials also know as “clinical investigations”.
Clinical Trials
EU 2017/745, the requirements for medical device clinical trials are part of Art. 62 through 82 and Annex XV.
Types of Medical Device Clinical Trials
FAQ's
How to conduct medical Device Clinical Trials
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Data Protection and Medical Device Clinical Trials
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Application Documents
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Role of Sponsor
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Ethics Committee
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Reduced burden for your employees
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