“Jacqueline Minor, director of consumer affairs at the European Commission, with oversight for medical devices, met [on 10 February] with Elena Santiago Cid, director general of the European standards committees, CEN and CENELEC, to discuss the matter of the commission’s Formal Objections against the 11 European medical device standards,” reports Amanda Maxwell in Clinica (subscription required). No details have been made public from that meeting, but CEN made it clear that it felt the objections were not justified.
The crux of the disagreement seems to be the assumption among Brussels overseers that the standards should mimic the Essential Requirements of the medical device directives when, in fact, many of them are drafted from a global perspective.
A post on the Eucomed blog authored by Andy Vaughan on behalf of the Association of British Healthcare Industries offers some additional insights into the brouhaha. “What the EU Commission’s Formal Objections illustrate is a system that is growing up and having to work with more globalised and integrated world economies,” writes Vaughan. Read all about it on the Eucomed blog: “New Approach – Making Standards Even Better.”Norbert Sparrow