Ireland is balking at proposed tougher medical device regulations in the European Union, a major voice of opposition as member states work to hash out a final law.
Proposed changes would, in part, add a new bureaucratic layer to the process--a body of experts designed to handle regulating high-risk devices. There would also be an implant registry, among other changes. But as the Irish Times reports, James Reilly, the country's minister for health, objects to adding a new approval layer to the process.
Reilly, following a meeting of EU health ministers in Brussels, threw his support behind the independent organizations known as "notified bodies," which approve most devices on a relatively quick timeline. Proposed changes would boost requirements for the groups to make sure they meet "up-to-date qualification requirements" and add a new regulatory arm to assess high-risk devices and implants.
"There really is very little to be gained, I believe, from having yet another layer of pre-authorization in place which will only serve to slow down the access of EU citizens to these medical devices, many of which are truly life-saving," Reilly is quoted in the article as saying.
His words echo the sentiment of the medical device industry in Ireland and industry groups around the world, which have argued that the new rules could add too much bureaucracy and give the U.S. the advantage in terms of medical device product development. Ireland's position carries added weight, because many medical device companies maintain manufacturing or research operations in the country.
There is still time to change the final outcome, so dissent matters. In October, the European Parliament advanced its proposed regulatory changes. And EU member states and the European Council must vote, after which Parliament and council members will develop a final law.
Why make the changes? Blame the now-defunct French company Poly Implant Prothèse (PIP), which created a scandal a few years back after word got out that it had made substandard breast implants for years. The case sparked a movement to toughen the European medical device regulatory approval process. Five former PIP executives were recently sentenced in the matter after a trial earlier this year.
- read the full Irish Times story