The European Commission's proposal to give member countries the ability to review medical device regulatory risk assessments conducted by notified bodies doesn't go far enough, consumer advocates testified at a Feb. 26 meeting. Regulators, meanwhile, will likely debate the idea further on April 24-25 in Dublin, EurActiv.com reports.
There are conditions, of course. As the article notes, countries would gain this power for Class III or higher-risk devices that affect public health. New technology would also face the extra scrutiny, as would particular notified bodies with a spotty track record. The added regulatory layer would be a step up in the wake of a scandal over how EU regulators scrutinize device implants. Gaps in the system were laid bare in the wake of a scandal in late 2011 over substandard breast implants, and continued scrutiny over faulty metal hip implants. In the wake of this, device companies and European lawmakers themselves met on Feb. 26 to begin hashing out a way to toughen medical device regulations in such a way that would protect patients but not create obstacles to business and innovation.
But German member-of-parliament Dagmar Roth-Behrendt, was among those who spoke at the Feb. 26 meeting advocating even tougher changes.
"I think our friends at the Commission need some help from the European Parliament just to make the system sound for patients as well as for procedures," Roth-Behrendt is quoted as saying. She said the system for procedures isn't good, and that she would want added scrutiny of the EU's device classification system, pre-market approval processes and the notification system itself, the story explained.
Either way, the status quo for device regulation needs changing, Monique Goyens, director general of the European Consumers' Organization, said in the article.
"In reality," she said, "the current legislation is less strict than for medicines and even sometimes for food."
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