[TECH LETTER] GSPR 12. Requirements for devices incorporating active substances or substances absorbed by or locally dispersed in the human body

Manufacturers producing substance-based medical products are often confronted with the question of finding which European legal framework is applicable.


Depending on the mode of action, their product can be regulated by Directive 2001/83/EC relating to medicinal products for human use (MPD) or by the Medical Device Regulation 2017/745 (MDR).


The objective of this Downloadable Techletter is to support manufacturers in this process.


Please submit the form: