Tighter restrictions on medical device developers have left some companies in the EU reeling, with their ambitious plans for products stymied by regulatory strictures that will make manufacturing and commercialization a constant uphill battle. Following the installation of new rules meant to prevent another health scandal like 2010’s ruptured breast implants from the disgraced Poly Implant Prothese, all companies in the sector must adhere to a more rigorous process of applying for certifications for their medical equipment.
One company that has been feeling the squeeze is Osypka AG, which makes newborn surgical gear that has become a mainstay in the European market. The EU’s vice-like grip on safety criteria has essentially priced the company out of continuing many of its product lines, and it has already withdrawn five lines of devices common to EU markets.
Some of those lines have experienced enduring market popularity that began as far back as 30 years ago. "A law created to stop one criminal company's actions 10 years ago now endangers patients' lives, including children, and European manufacturing sites," said molecular biologist and company leader Nicola Osypka. "Is that what the EU wants for its citizens?"
Osypka AG can be counted among eight other organizations that have taken flagship devices off the EU market or have halted production due to the inflated cost associated with regulatory compliance. The EU’s Medical Devices Regulation (MDR) from May 2021 demands that all medical devices ranging from prosthetics to blood glucose meters have to meet much stricter safety standards, even in clinical trial situations.