The Challenges of Setting Up a Clinical Study with the New European Union Medical Device Regulation

The new European Union Medical Device Regulation (MDR) – Regulation EU 2017/745, which came into effect on May 26, 2021, expands the scope of medical devices to “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; (…)” (MDR – Article 2),1 and therefore has had a significant impact in the medical devices industry.

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