The past few years have seen a tremendous development of injectable drugs with devices that allow patients to self-administer their therapy in an easier, safer and freer way. They no longer need to go to their doctor or hospital as often and become more independent and flexible actors in managing their condition. These new therapies and the emergence of new technologies are causing a booming of the pharma sector!
This trend has also been followed by European legislators in issuing a new Medical Devices Regulation (EU 2017/745 MDR) which will come into force in 2021 (postponed from 2020 to 2021 by the European Commission due to the Covid-19 pandemic). Indeed, from the entry into force of the MDR, it will become mandatory to provide either an EU declaration of conformity or an opinion from a Notified Body on the device constituent for registering a new combination product. And this will bring lots of new challenges for the pharmaceutical companies.
Read a detailed review of the new challenges of injectable medicines.