Trifork Digital Health has achieved CE marking under the EU Medical Device Regulation (MDR) for Shared Medication Decision Support (FMB), developed with the Danish regions and integrated into clinical systems across Denmark. The solution supports doctors in making decisions about prescription medication. Trifork Digital Health has also obtained MDR certification from BSI for its quality management system, supporting its ability to develop regulated medical device software for other customers.
When a doctor prescribes medication or reviews a patient's medication list, FMB can provide patient-specific decision support directly within the doctor's clinical system. FMB is designed to support clinical decisions relating to the use of prescription medication.
What makes FMB distinctive is that it is not a standalone clinical system. Instead, the solution integrates with other clinical systems across the healthcare sector and can provide decision support directly within the systems healthcare professionals already use.
Because FMB supports clinical decisions related to medication, the solution is classified as a Class IIa medical device under the EU Medical Device Regulation (MDR).
As part of the process, FMB underwent a conformity assessment with BSI as the notified body. This included an assessment of the technical documentation, risk management and clinical benefits. The CE marking therefore represents extensive work on documentation and risk management, with a focus on the safe use of the solution.
“We congratulate Trifork Digital Health and its partners on achieving CE marking for FMB under the Medical Device Regulation—an important milestone in bringing innovative digital health solutions safely to market,” says Thomas Doerge, Global Head Active Implantable Medical Devices and SaMD at BSI.
"Developing medical software is no longer just about functionality. Today, we must be able to demonstrate to an even greater extent that a solution performs consistently and predictably, that users can us it correctly, and that potential risks are monitored and managed throughout the product's lifecycle," says Jesper Carøe, CEO of Trifork Digital Health.
Trifork has developed medical device software under the previous Medical Devices Directive (MDD) for several years. Trifork Digital Health has now obtained MDR certification from BSI covering its quality management system for medical device software development, alongside the CE marking of FMB as Class IIa medical device software.
Trifork Digital Health is also certified to ISO 13485, the international standard for quality management systems for medical devices. Together, these certifications and the experience gained through FMB provide a foundation for developing regulated medical device software for other customers under MDR. Each product remains subject to its own applicable regulatory requirements and conformity assessment.
“We do not see the CE marking of FMB as the end of a project. On the contrary, it provides a foundation we can build on. Both in the continued development of FMB and in our work on other digital health solutions, where regulatory requirements need to be considered from the outset,” says Jesper Carøe.
Facts About FMB: FMB is used across Danish healthcare sector supporting doctors by providing decision support when prescribing medication or reviewing medication list. Patient-specific data including prescription medication is compared with medicinal product data and clinical guidelines, with relevant messages presented to doctor who retains final decision responsibility.
About Trifork
Trifork is a global technology company specialising in the design, development and operation of advanced software solutions for businesses and the public sector. With 1,122 full-time employees across 16 countries, Trifork serves as an end-to-end technology partner for organisations in complex and regulated industries, including public administration, healthcare, financial services, energy and aviation.
Trifork develops digital health solutions and advises healthcare authorities, regions, hospitals, and life science companies. The business area combines software development with in-depth knowledge of clinical workflows, interoperability, and international standards, and has contributed to solutions including MinLæge, Fælles Medicinkort and Fælles Medicin Beslutningsstøtte. Trifork Digital Health is ISO 13485 certified and has many years of experience in developing regulated medical software.
