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The EU’s new Medical Device Regulation has recently come into effect. As a result, hospitals need to be aware of the new regulations and ensure that the medical devices and medical device software they use are compliant. This will help secure the safety and efficacy of the medical device software they use and promote better patient outcomes. And rest assured, we have already made the Ascom Healthcare Platform compliant and certified for use in the areas affected by the new regulations.
First a little background. On 26th May 2021, the EU implemented the Medical Device Regulation (EU) 2017/45 (MDR), which standardizes the legislation and updates the requirements around medical devices from the almost 30-year-old Medical Devices Directive 93/42/EEC (MDD). Among other topics, MDR specifically deals with software as a medical device, post-market surveillance and the obligations of the various stakeholders.
Key MDR takeaways for hospitals and users
· Definition — Medical device software is defined as any software intended to be used for diagnostic or therapeutic purposes.
· Classification — Medical device software is classified based on its intended use and level of risk.
· Compliance — Manufacturers of medical device software must demonstrate compliance with the MDR by obtaining a CE mark, which indicates that the software meets the necessary safety and performance requirements. If in doubt, ask your suppliers for their certification.
· Clinical evaluation — MDR requires that medical device software undergo clinical evaluation to demonstrate its safety and effectiveness. Hospitals should be aware of the results of these evaluations when selecting and using medical device software.
· Post-market surveillance — Manufacturers must monitor the performance of medical device software in the market and report any adverse events associated with its use. Equally, hospitals should report any adverse events they experience to the manufacturer.
· Quality management system — MDR requires that manufacturers of medical device software implement a quality management system to ensure that the software is designed and developed in a consistent and controlled manner. Hospitals should be aware of the quality management systems in place for the medical device software they use.