Medical device makers drop products as EU law sows chaos

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, Qazet.az reports.

Under the regulations designed to prevent another health scandal, such as the one in 2010 involving ruptured breast implants made by Poly Implant Prothese, companies must apply for new certificates for their medical equipment.

But Osypka says the small firm founded in 1977 by her father Peter cannot afford the process and it has withdrawn five lines of devices sold in the EU, some for more than 30 years.

"A law created to stop one criminal company's actions 10 years ago now endangers patients' lives, including children, and European manufacturing sites," said Osypka.

"Is that what the EU wants for its citizens?"

Osypka AG is one of eight companies Reuters has spoken to, including Swedish medical equipment maker Getinge (GETIb.ST), that are withdrawing devices from the EU market, or have stopped making them due to the cost it takes to comply with the rules.