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JST Healthcare Solutions receives EU MDR certification for Smart Symptom Check software

23.04.2025

JST Healthcare Solutions today announces that Smart Symptom Check has successfully been certified and CE-marked as a Class IIa medical device under the European Union Medical Device Regulation (EU) 2017/745 (MDR). This certification is a significant milestone, confirming JST’s dedication to safety and performance.

What MDR Class IIa certification means in practice: 

• Confirms the safety and performance of Smart Symptom Check, validating our commitment to high-quality standards and industry best practices. 

• Ensures continued market access in the EU also beyond 2028, after the end of the MDD transition period. 

• Enables faster, more flexible product development, including the introduction of new features while maintaining compliance. 

The MDR is the medical device regulation applied by the European Commission. The MDR became applicable in 2021 addressing the need for stronger patient safety, more rigorous clinical evaluation, and greater transparency across the EU medical device market. It ensures stricter oversight, continuous post-market monitoring, and clearer accountability for all economic operators involved. MDR replaces the old Medical Devices Directive (MDD), in place since the 1990s.  

Unlike MDD medical devices currently operating under the MDR transition period which is valid until 2028, our product now complies fully with the stricter, more comprehensive MDR requirements. This positions us ahead of the competitors in terms of regulatory readiness and market sustainability in the EU. In addition, this enables faster and more versatile product development and adding new functionalities to the software, as significant product changes were not permitted during the MDR-transition period. 

Smart Symptom Check is among the first virtual triage software to be certified as a class IIa medical device in Europe. Smart Symptom Check streamlines and accelerates care needs assessment making it systematic, structured and consistent. It transforms symptoms into structured data that enables care path optimization.  

To achieve Class IIa classification, JST Healthcare Solutions had to demonstrate that its Smart Symptom Check software and quality management system (QMS) fully comply with the MDR’s rigorous safety and performance requirements. This process included comprehensive external audits and the submission of detailed technical documentation for evaluation by a Notified Body, SGS Fimko Oy — an independent third-party certification authority. In addition, JST’s quality management system, as certified by SGS Fimko Oy, is compliant with ISO 13485, a harmonized international standard for Quality management system in the medical device industry. 

Johannes Kallio, Co-Founder and Chief Executive Officer, commented the MDR-certification: 

“Achieving MDR certification is a significant milestone for JST Healthcare Solutions and a powerful validation of the safety, performance, and medical quality of our Smart Symptom Check software. The EU MDR is one of the most rigorous regulatory frameworks in the world, and meeting its standards reflects our deep commitment to patient safety and clinical excellence.”