Medicinal products & medicinal substances incorporated in medical devices

White papers - 22 October 2020

Medicinal products & medicinal substances incorporated in medical devices

The implementation of the European Medical Device Regulation, Regulation (EU) 2017/745 (MDR) and the publication of numerous guidelines could increase the already existing confusion about the association of medicinal product or medicinal substance with medical device. The objective of this whitepaper is to provide a support on the management of initial submission to EMA (European Medicines Agency) of such association according to version 1 of EMA Guideline recently

Did you like this article? Share on social networks:


    By sending this form, I agree that my personal data will be saved and processed according to data protection regulations and will be used only for commercial and marketing purposes only.

    Learn more


    BlueReg undertakes to comply with the regulations in force applicable to the processing of personal data and, in particular, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 applicable as from 25 May 2018 (hereinafter, "the General Data Protection Regulations" or GPDR) and the national laws resulting therefrom.
    Any inquiries, correction or declaration of event related to personal data processed should be sent to: GDPR data request

    Thank you for your reply

    The file will be sent to you by email.

    Download