New Anti-Counterfeit Device Legislation Comes Into Force In 2016
This article was originally published in Clinica
The new Medicrime Convention, which aims to combat the sale of medical devices and diagnostics that do not comply with local regulations, as well as the sale of counterfeit medicines, is coming into force on Jan. 1
You may also be interested in...
With less than one hundred days left before the European Union Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss growing concerns by medtech industry members that they may not be ready in time to comply with these regulations and may inadvertently go afoul of the new regulations.
What will the fall-out of political tensions between the EU and Switzerland mean for notified bodies based in Switzerland, and for the future recognition of CE marks granted in one of the most important medtech markets in Europe?
Eighteen years of free trade threatens to come to a sudden stop, as a result of the stalemate in the market access agreement between Switzerland and the EU. Industry association Swiss Medtech is advising local medtech manufacturers to find notified bodies and authorized representatives based in the EU. However, local company SQS remains confident of its ongoing notified body role.