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72 Maria Lindgren, Director Clinical Development,
Key2Compliance Software (defined as a set of instructions that processes input data and creates output data) now falls under classification Rule 11 in the MDR. However, not all software used within healthcare is qualified as a medical device, Lindgren and Dahlin emphasize. “Many medical device software (MDSW) will be re-classified, leading to that these products will need the involvement of a notified body. For all MDSW, the manufacturer should ensure safety and performance throughout the lifecycle, through a continuous process of clinical and/or performance evaluation and risk management,” says Dahlin. Software for which the manufacturer claims a specific medical intended purpose, i.e. the software has a clinical benefit, needs to have clinical evidence within its own conformity assessment. “You also need to consider cybersecurity requirements (listed in Annex I General Safety and performance) of the MDR, which deals with both premarket and post-market aspects. Privacy and confidentiality 72 NORDICLIFESCIENCE.ORG of data associated with the use of MDSWs that may be outside the scope of the MDR are subject to other legislation,” explains Dahlin. Finally, we asked Maria Lindgren and Helena Dahlin to share their best advice to companies affected by the new regulation, and they highlighted a few important take-away messages. “State which requirements apply to your device and follow a plan to fulfill them. Regulatory requirements concerning your products and your quality system must both be included. Also, consider important timings and the workload of notified bodies, and that it takes time to collect clinical data,” says Lindgren. “It is also important to prepare your organization for the changes, empower and train your staff, and do not forget the liability aspects for defective devices. Finally, keep an eye on the range of guidance documents on the European Commission’s website,” adds Helena Dahlin. NLS