Borderline products: the practical case of medical devices

In the field of cosmetics, the notion of "borderline product" remains very present. Such status implies different factors that may lead manufacturers to one regulation or the other (cosmetics, biocides, medical devices, etc.).

However, given the complexity of this concept and the multiple boundaries between the various cross-cutting regulations, no proper text has yet established specific rules. Only guidebooks have been drafted by European Commission working groups in order to provide guidance to Responsible Persons.

Thus, only one status must be chosen since the principle of non-accumulation of regulations prevails. The function of the product therefore remains the key criterion to determine its regulatory status.

To which regulations must your product comply? How to define and categorise products defined as "borderline" with several regulations? 

Agenda :

• Classification of different cosmetic-like products
• Case study