It has been a long time coming, but the European Union has finally reformed the current medical device legislation. The whole ordeal started back in 2012 with two proposed regulations, one for medical devices and one for in vitro diagnostics (IVDs). These new regulations were aimed at producing better quality and safety for patients. While scientific and technological advances has skyrocketed in previous years, medical device and IVD legislation has still lagged behind. The wait to bridge that gap is finally coming to an end after a long and difficult legislative process.
Manufacturers will now be scrutinized with stricter post-market surveillance requirements. The risks of any device must be offset by acceptable likelihood of benefits. Companies will be required to submit periodic safety update reports annually and respond to public health threats swiftly and with their full force. This model has worked well for pharmaceutical companies, so it is expected to translate well to medical devices.
Although some in the industry may disagree with these provisions, it is a sign of progress to finally be moving once again. With safety checks and surveillance requirements, devices like new EKG machines and dopplers will be ready for patient use. Give your patients the best possible care by purchasing through Medical Device Depot, which stays up to date on all of the latest rules, regulations and legislation in the industry.