Implantable device regulation in Europe

摘要

We agree with Norman Williams (May 12, p 1789)1 about the unsatisfactory nature of the current regulatory framework for implantable devices in the UK (and European Union) and are heartened to see the Royal College of Surgeons leading this debate.It is hard to understand how a system so manifestly unfit for purpose has evolved, the commercially privileged relationship between manufacturer and assessment body being the most obviously inappropriate aspect of a flawed structure.