No exemption for medical devices or IVDs (in vitro diagnostics) in EU's REACH, as Parliament and Council strike informal deal
This article was originally published in Clinica
Executive Summary
There is to be no escape for the medtech industry, and particularly the in vitro diagnostics industry, it seems, from new restrictions on the materials that they can use in manufacture and processing of their products as a result of the latest developments on the EU's REACH chemicals safety bill. The European Parliament and the Council have worked out an informal deal on the text, with little to now derail it. And medical devices and diagnostics are included within its scope.