EU reaches agreement on new medical device and IVD regulations

The agreed two draft regulations are expected to achieve a two-fold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner,” said the European Council in a press release issued on May 25. For medical device OEMs and their supply chain doing business in Europe, the rule requiring unannounced audits has the potential to cause the greatest disruption.