The EU trialogue is moving along, with members discussing legislative proposals for regulations that would change the way medical devices and in vitro diagnostics are regulated. As talks progress, experts are advising devicemakers to choose their notified bodies carefully.
Gert Bos, head of regulatory and clinical affairs at BSI, told attendees of the recent Regulatory Affairs Professional Society Convergence Conference in Baltimore, Md., that 25 percent of notified bodies have stopped operations ahead of the upcoming regulations. He added that it isn’t outside the realm of possibility that another 25 percent could disappear.
“If you are responsible for interaction with the notified body, make sure management is aware of what’s going on,” Bos said. “If you have to change [your] notified body, start preparing,” added Hendrik Heinze, director of quality and regulatory affairs at Berlin Heart. He added that, as a small company, it was especially important for Berlin Heart to adapt to the changes early, so it was quick to try out the Medical Device Single Audit Program. The program, developed by the International Medical Device Regulators Forum, represents “a good chance to reduce the workload for small companies.”
Their caveats came as the EU Council, Parliament and Commission get ready to hammer out a set of proposals on which all three can agree (). Erik Hansson, deputy head of unit, DG Health and Consumer Protection, cautioned that although they hoped to reach an agreement before the end of the Luxembourg presidency, timelines may slip. An agreement could be realized early next year, meaning the regulations could be adopted at the end of the spring.
Issues that could warrant additional discussion include a scrutiny mechanism for high-risk devices, reprocessing of single-use devices and unique device identification.
For those notified bodies that remain standing, Bos predicted that they’ll need to hire a lot of additional staff — something that already is occurring. In addition, there could be a decreased belief in harmonized standards and a potential emphasis on unannounced inspections — something Bos said he hopes won’t happen.
As devicemakers prepare for the regulations, one member of industry had a word of caution: make sure you have the right people in place at your organization. David Rutledge, director of clinical research at Abbott, told the audience that they need to start hiring the right people now, as “it takes time to develop the expertise.”
He said that people who have a real knowledge of risk management will be of particular value, adding that his company had taken a “sober look” at their knowledge base. “We have learned that we might not have the right people at our company,” he added. As you prepare them to appreciate risk, realize that you eventually will have to retrain them, he added. — Elizabeth Hollis