Interview: EU Or US? Deciding On The Best Market Entry Point Amid Evolving Clinical Requirements
The timescale for CE-marking devices that require clinical studies may stretch to at least double the timescale for US 510(k) clearance as the EU landscape evolves, according to consultant Maria Donawa. In a Q&A with Medtech Insight, she assesses the ongoing changes and whether the clinical data requirement scales are tipping to such an extent that the US will increasingly be a favored point-of-market entry.
You may also be interested in...
More robust oversight of medical devices in the EU is coming, and some European cardiologists speaking at the Transcatheter Cardiovascular Therapeutics annual meeting in Washington, DC, said that is a good thing despite the device industry’s history of praising the EU system for supporting innovation. They also pushed for more harmonization between the EU and US systems. Watch a video report from an FDA Town Hall panel at TCT on the topic and read our report from the meeting.
Are EU notified bodies raising the bar too high when it comes to assessing manufacturer compliance against the current Medical Devices Directive and Active Implantable Medical Devices Directive? Industry says it is challenged by notified bodies’ use of the latest EU clinical evaluation guidance document.
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.