The European Medicines Agency (EMA) has recently revised the Question and Answer (Q&A) document that provides practical considerations concerning the implementation of the medical devices (MDR) and the in vitro diagnostic medical devices (IVDR) regulations.
The Q&A document has been developed to provide guidance to applicants on aspects within the scope of the Agency’s activities and should always be read in conjunction with the new MDR and IVDR.
The recent update of this document focuses on aspects relating to the implementation and applicability of the requirements of Regulation (EU) 2017/745 to medicinal products with an integral or co-packaged medical device.
Asphalion is supporting a large number of companies during development, manufacturing, validation, certification and commercialization of Medical Devices in Europe and United States, according to the applicable legislations.
If you are interested to obtain specialized advisory about how to accomplish European Commission requirements about fair market access for Medical Devices, please contact us at: [email protected]