VdTÜV Position: Limits and opportunities in TTIP with respect to medical devices

Recognise European CE marking for medical devices on the US market
© mattiaath - Fotolia.com

In the EU, medical devices can only enter the market by affixing the CE marking. This label is based on a self-declaration by the manufacturer. The CE marking is not yet recognised in the USA; the same applies to US approvals in Europe.

The European conformity assessment system for medical devices has proven its value in past years. It ensures that medical devices are conformant and safe. Current studies conclude that, despite different market access systems, the safety level of medical devices is in effect comparable. However, the system in Europe translates into new medical devices entering the market more rapidly than in the US. European patients can therefore benefit from innovative medical technology at an earlier stage. Within the course of the Transatlantic Trade and Investment Partnership (TTIP) negotiations, the reliable European regulatory approach must be maintained, in order to ensure the supply of innovative and safe medical devices in Europe.

The full paper is available for download below.