The United States wants the European Union to delay implementing the E.U.’s new Medical Device Regulation system (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR) by three years, according to a report by the Regulatory Affairs Professionals Society (RAPS).
RAPS cites a July 24, 2019, letter to the World Trade Organization’s Committee on Technical Barriers to Trade, in which the U.S. expressed “serious concerns” that the world will lose access to the E.U.’s $125 billion medtech market, which includes $20 billion of U.S. products.
The E.U. faces a May 2020 deadline to put the new regulatory system in place. First, it must approve more notified bodies (NBs) to assess the conformity of new devices’ with MDR or IVDR before they can go on the market, and to oversee transitions to compliance by existing devices. The E.U. and its member states have so far designated two notified bodies for medical devices.
If the E.U. cannot delay implementation by three years, the U.S. asked that it “allow for legacy products that are currently deemed safe to be sold on the market until 2024” and to ask NBs to prioritize devices that need new certification over those being recertified, the RAPS report said.
Europe’s medical device trade group warned the European Commission in April that if MDR is not ready by the deadline, E.U. medtech companies will take their business elsewhere.
It’s a step in the right direction, but that’s all. There’s much more at stake than the $20 Billion USD.
How many products will no longer be available to the Europeans post 05/2020? I would estimate thousands will vanish from the market permanently. Small manufacturers and niche products will vanish due to exceptionally high costs to re-certify and monitor the products. Costs associated with clinical work and subsequent reporting for low volume legacy products may exceed the products annual revenues, making it cost prohibitive to re-enter the market for many companies. Overall, it is a significant cost barrier to EU market entry for new companies as well.
My understanding is that the European Commision were already considering an extension but 3 years seems excessive. Dont understand how WTO would see it as anti-European business because the Regulation applies to Europeans also. However they have similar complaints