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: info@asphalion.com

Subscribe to Directory
Write an Article

Recent News

Exposure to Heat and Cold During Pregnan...

The research team observed changes in head circumf...

Using mobile RNAs to improve Nitrogen a...

AtCDF3 gene induced greater production of sugars a...

El diagnóstico genético neonatal mejor...

Un estudio con datos de los últimos 35 años, ind...

Highlight

Eosinófilos. ¿Qué significa tener val...

by Labo'Life

​En nuestro post hablamos sobre este interesante tipo de célula del...

For the first time scientists managed to...

by IBEC - Institut de Bioenginyeria de Catalunya

These are asembloids, micrometric organoids formed by the union of kid...

Photos Stream