EC looks into parallel imports of medical devices:
This article was originally published in Clinica
Executive Summary
The issue of parallel imports in now high on the European Commission's agenda, with the medical devices unit within the Commission having invited its lawyers to compile all available information on European rules rulings to build up a picture of what the current practice in the medical devices area is and compare it with practice for products covered by other CE marking directives. One of the subjects that will be looked at will be to what extent the language of the instructions for use and labelling can be made available, and under what conditions, to parallel importers. This matter could be on the next Medical Device Experts Group meeting on June 28-30. If not, it is likely to be discussed at the next meeting after the summer break, probably in October.