What is a "health institution", the EC asks?:
This article was originally published in Clinica
The European Commission's medical device unit is to develop a position paper on the definition of the term "health institution". Questions have been raised over what is covered in its scope, not least in connection with issues concerning the manufacture of in-house products. The objective of the working group that has been set up by the Commission to look at this issue is to develop a statement of understanding or a guidance document on the term; it does not want to introduce another change in the proposal for an amendment to the Medical Devices Directive.