LONDON, Dec 19 (Reuters) - Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make tough decisions.
While some companies say the products they have cut have no impact on patients or profits, others say some of withdrawn devices are essential, and doctors agree.
Under the EU's Medical Devices Regulation (MDR), which came into effect in May 2021, all medical devices, from implants and prosthetics to blood glucose meters and catheters, must meet stricter safety criteria, sometimes with new clinical trials.
Under the old system, it took about 15,000 euros and a few months to get a similar device approved, he said.
Tom Melvin, an associate professor of medical device regulatory affairs at Trinity College Dublin, said there were nearly 100 such agencies a decade ago under the old system.