The AIS-1 medical device

The AIS-1 is an in-house medical device (class IIa) that has been developed to be used locally by the Department of Surgery, Zealand University Hospital Denmark, as the specific needs of target patient groups cannot be met, or cannot be met at the appropriate level of performance, by an equivalent CE-marked device available on the market. The Department of Surgery adheres to the conditions laid out in Article 5(5) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. The AIS-1 is designed to be used as decision support tool for surgeons managing the perioperative care planning of patients undergoing curative intended elective surgery at the department for colorectal cancer. 

  • AIS-1 Declaration of Conformity

The declaration of conformity can be found her.