Think that Europe is more welcoming to medical devices? It may...

Think that Europe is more welcoming to medical devices? It may not be for long
The grass is greener on the other side.

That is traditionally how device makers have viewed Europe when it comes to medical device regulation and theease of getting products approved and commercializedcompared to the U.S.

Well, looks like storm clouds are approaching.

In the wake of the PIP breast-implant scandal, European regulators are taking a hard look at their system. In late April, the European Parliament called for a premarket authorization system in Europe for certain medical devices.

That was just one measure proposed by theEnvironment and Public Health Committee. Others included the creation of a breast implant registry, more strict checks and product traceability.

“It is essential to learn from this fraud and to strengthen surveillance and safety controls, and placing on the market requirements” for medical devices, including breast implants,” reads the Parliamentary resolution.

The committee has also called for the establishment of a single European database that will house information about medical devices on the market as well as “registration of economic operations, vigilance and market surveillance; clinical investigations, notified bodies and EC certificates issued.”

If these measures are passed, expect Europe to become a bit more difficult terrain to move forward.