BRUSSELS, Belgium — For those concerned about the revision of rules governing the popular CE mark for commercializing medical devices in Europe, let's say we are somewhere in the third quarter.
BRUSSELS, Belgium — Where coverage with evidence development (CED) programs are well-established, though applied sparingly, in North America such early market access schemes for medical devices are new to Europe. And characteristic of the fragmented regulatory landscape found here, the approaches and requirements vary greatly among 30-plus countries.
