The new EU Medical Device Regulation comes into effect in May 2021. That means everybody up and down the supply chain has new compliance responsibilities, a major change from the current Medical Device Directive. Failure to comply can lead to market recalls, banned goods, and even prosecution. With over 125 years of experience, Ansell has the expertise, QA systems, and product requirements in place to ensure full MDR compliance.
Under the new MDR, the legal responsibilities of companies that sell private label gloves or act as fulfillment partners may change. Download this decision tree to see what role your company will have under the new MDR.