There are several issues I feel are hot right now: - Differing registration requirements in EU Member States affects the ability to gain reimbursement - Clinical trial reporting requirements for trials started prior to 21Mar10 - Unique Device Identification (UDI) is coming and companies should get involved now to understand it as it affects the whole supply chain - Software classification of all kinds (patient records/data handling, and more importantly when s/w is used in the diagnosis of the patient and involves some form of processing/interpretation)