Many medicinal products are designed for use with a medical device or part of a medical device. Given the wide range of medical devices or parts of medical devices that may be used with a medicinal product, new provisions have been introduced in Article 117 of Regulation (EU) 2017/745 to demonstrate the conformity of these medical devices or parts of medical devices.
The implementation of these provisions is the responsibility of the pharmaceutical companies applying for marketing authorization.
In this newsletter, we will detail the requirements of Regulation (EU) 2017/745 relating to the marketing of combined drug-device products. We will discuss when the intervention of a notified body is required, as well as the steps to obtain a Notified Body Opinion (NBOP). Finally, we will guide you through the selection of a notified body and the available documentary resources.
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