{"url":"https://newsforagent.com/news/2026-11-03/trifork-digital-health-mdr-ce-marking-fmb","markdown_url":"https://newsforagent.com/news/2026-11-03/trifork-digital-health-mdr-ce-marking-fmb.md","title":"Trifork Digital Health Wins CE Mark for FMB Medication Tool","headline":"Trifork Digital Health Secures MDR CE Marking for Nationwide Medication Support Tool","description":"Trifork Digital Health has achieved CE marking under the EU Medical Device Regulation for its Shared Medication Decision Support tool, classified.","section":"Regulation & Approvals","published_at":"2026-11-03T06:44:11+00:00","modified_at":"2026-11-03T06:44:11+00:00","author":"News Desk","key_takeaways":["Trifork Digital Health achieved CE marking under the EU Medical Device Regulation for Shared Medication Decision Support (FMB), a Class IIa medical device.","BSI certified Trifork Digital Health's quality management system under MDR after a conformity assessment covering technical documentation, risk management and clinical benefits.","Trifork Digital Health is also certified to ISO 13485, the international standard for medical device quality management systems."],"companies":[{"name":"Trifork","is_primary":true,"profile_url":"https://akta.pro/company-profiles/0003z61/trifork","website":"http://www.trifork.com"},{"name":"BSI","is_primary":false,"profile_url":"https://akta.pro/company-profiles/0006736/bsi","website":"http://www.bsigroup.com"}],"source":{"publisher":"TradingView","title":"Trifork strengthens its medical software capabilities with MDR certification and CE marking of nationwide medication solution","url":"https://www.tradingview.com/news/globenewswire:80fb21bc2094b:0-trifork-strengthens-its-medical-software-capabilities-with-mdr-certification-and-ce-marking-of-nationwide-medication-solution/"},"other_sources":[],"tags":["Regulation & Approvals","Trifork","BSI"],"body_markdown":"Trifork Digital Health has achieved CE marking under the EU Medical Device Regulation for Shared Medication Decision Support (FMB), a tool integrated into clinical systems across Denmark, the company said in a [TradingView](https://www.tradingview.com/news/globenewswire:80fb21bc2094b:0-trifork-strengthens-its-medical-software-capabilities-with-mdr-certification-and-ce-marking-of-nationwide-medication-solution/) press release dated November 3, 2026. The solution is classified as a Class IIa medical device.\n\n## How FMB Supports Danish Prescribing\n\n[Trifork](https://akta.pro/company-profiles/0003z61/trifork) Digital Health developed FMB with the Danish regions. When a doctor prescribes medication or reviews a patient's medication list, FMB can provide patient-specific decision support directly within the clinical system the doctor already uses. The tool collects patient-specific data, including prescription medication information, and compares it with medicinal product data and clinical guidelines. Relevant decision support messages are then presented to the doctor, who remains responsible for the final decision.\n\nFMB underwent a conformity assessment with BSI as the notified body, covering technical documentation, risk management and clinical benefits. Trifork Digital Health also obtained MDR certification from BSI for its quality management system for medical device software development. The company is certified to ISO 13485, the international standard for medical device quality management systems.\n\n\"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,\" said Jesper Carøe, CEO of Trifork Digital Health.\n\nThomas Doerge, Global Head Active Implantable Medical Devices and SaMD at [BSI](https://akta.pro/company-profiles/0006736/bsi), said: \"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.\"\n\n## Trifork's Health Data Contracts\n\nAccording to akta.pro [company records](https://akta.pro/company-data), Trifork subsidiary Netic won an eight-year contract with the Danish Health Data Authority in February 2026 for health data infrastructure services. In November 2025, Trifork and Swiss Post formed a partnership to advance digital transformation of healthcare infrastructure in Switzerland. Trifork reported full-year 2025 revenue of EUR 220.9 million, 7.2% year-over-year growth, and projects EUR 230-240 million for 2026.\n\n## Trifork's Recent Quarter\n\nTrifork Group reported third-quarter 2026 revenue of EUR 61.0 million, up 24% year-over-year, with organic growth of 28% and adjusted EBITDA growth of 40%, according to TradingView. Products revenue rose 76% to EUR 27.7 million, and the company narrowed its 2026 financial guidance within original ranges. On October 28, 2026, shareholders approved all resolutions at an extraordinary general meeting, including a DKK 3.00 per share dividend from capital contribution reserves, Yahoo reported.\n\n## What Comes Next for FMB\n\nTrifork Digital Health said the 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.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}