European officials are roughly 90 percent of the way toward reaching an agreement on new regulations for medical devices and in vitro diagnostics, but there are still points of contention, according to one expert.
Among the roadblocks is disagreement over the reprocessing of single-use devices, according to Paul Brooks, senior vice president of healthcare solutions at BSI. Brooks expects the regulation will provide a framework allowing member states to choose to either permit or prohibit the activity.
Under the proposal, reprocessors would be considered as re-manufacturers, meaning they would need to take responsibility for CE marking and compliance in the marketplace. However, hospitals that conduct in-house reprocessing may be allowed to deviate from the requirements, he said.
Proposed regulations also call for a scrutiny process for Class 3 implantable devices, requiring notified bodies to send CE certificates to an expert panel for review before they can make a decision on issuing a CE mark. Industry is concerned that the process could cause delays, creating less predictable clearance of the devices, Brooks said.
Industry is lobbying over a potential requirement for notified bodies to review Class 2b implants, effectively giving them a level of scrutiny normally reserved for Class 3 products. Industry is concerned the requirement could overwhelm the notified body system, which is already quite stretched.
“It’s getting much more difficult to be a notified body, and it’s going to be more difficult to be a notified body going forward,” said Brooks. Devicemakers are facing steep challenges due to a decline in the numbers of notified bodies, and industry is already seeing a culling of the weakest bodies ().
It was hoped the trialogue would conclude by Easter, but now it seems more likely that will occur in June, said Brooks. “Just because we have an agreement, doesn’t mean we have regulations,” he said during the FDAnews Medical Device Quality Congress earlier this month in Rockville, Md.
“Our best guess at BSI is that the earliest we can expect to see the regulations enter into force is the end of this year or the early part of next year,” he said. Even then, a transition period would give devicemakers three years and in vitro diagnostic manufacturers five years to comply. — Jonathon Shacat