Digital health technology is the integration of digital tools into healthcare to improve prevention, diagnosis, monitoring, and treatment. CE marking of digital health technologies is mandatory under the EU Medical Device Regulation (MDR). It ensures that software, apps, and connected devices meet EU safety, performance, and regulatory requirements. Hence, it is necessary to market your device in the EU.
What is digital health technology?
Digital health technology refers to the use of digital tools to improve healthcare delivery, diagnosis, monitoring, and patient well-being. It blends healthcare with information and communication technologies to make medicine more personalized, efficient, and accessible. Basically, digital health technology is the integration of digital tools, such as mobile health apps, wearable sensors, telemedicine platforms, electronic health records, and artificial intelligence, into healthcare. The aim is to improve prevention, diagnosis, monitoring, and treatment. It combines computing, connectivity, and data analytics with medical science to make healthcare more accessible, efficient, and personalized. Moreover, it enables remote consultations, continuous patient monitoring, predictive diagnostics, and secure data sharing. Thus, digital health technologies empower patients, support clinicians, and drive innovation in health systems.
Key categories of digital health technology
- Mobile health: Apps for fitness tracking, medication reminders, or chronic disease management.
- Wearables and sensors: Smartwatches, glucose monitors, ECG patches, and activity trackers.
- Telehealth and telemedicine: Remote consultations, video visits, and digital triage systems.
- Health IT systems: Electronic health records (EHRs), clinical decision support software, and interoperability platforms.
- Artificial intelligence (AI) and machine learning: Tools for medical imaging analysis, predictive diagnostics, and personalized treatment planning.
- Personalized medicine: Genomic data integration, precision drug dosing, and tailored therapies.
Benefits
- Improved access: Enables remote care for rural or underserved populations.
- Efficiency: Streamlines workflows, reduces paperwork, and enhances data sharing.
- Accuracy: AI-driven diagnostics and monitoring improve clinical decision-making.
- Patient empowerment: Individuals can track their own health metrics and engage in preventive care.
Challenges
- Data privacy and security: Protecting sensitive patient information under applicable regulations.
- Interoperability: Ensuring systems and devices can communicate across platforms.
- Regulatory oversight: Technologies with medical claims must comply with frameworks, such as EU MDR/IVDR or FDA regulations.
CE marking of digital health technologies
CE marking of digital health technologies in the EU is a mandatory certification under the EU Medical Device Regulation (MDR). It ensures that software, apps, wearables, AI tools, and electronic health systems meet strict safety, performance, and quality standards before being marketed. It requires manufacturers to classify their product, implement an ISO 13485-compliant quality management system, and prepare detailed technical documentation, including risk analysis and cybersecurity measures. Additionally, they are required to provide clinical evidence of safety and effectiveness, undergo review by a Notified Body for higher-risk devices, and maintain ongoing post-market surveillance. By affixing the CE mark, companies gain legal access to the EU market, while patients and clinicians are assured of compliance with essential health, safety, and data protection requirements.
Regulatory framework for digital health technology CE marking
- EU MDR (2017): Governs medical devices, including software intended for diagnosis, monitoring, or treatment.
- EU IVDR (2017): Covers in vitro diagnostic software and digital platforms used for lab/clinical testing.
- EHDS regulation (2025): Introduces mandatory CE marking for EHR systems, thereby harmonizing cross-border health data exchange
EU MDR guidelines for digital health technologies
The EU Medical Device Regulation (MDR 2017) sets the framework for how digital health technologies, such as medical software, mobile apps, AI-driven tools, and connected devices, are classified, assessed, and approved for use in Europe. It ensures that these technologies meet strict safety, performance, and quality standards before they can be marketed.
Core principles of EU MDR for digital health technology
- Scope: MDR explicitly includes standalone software and apps if they have a medical purpose (diagnosis, monitoring, treatment, or prevention).
- Risk-based classification: Software is classified based on its intended use and risk to patients. Diagnostic or therapeutic software often belong to Class IIa or higher, requiring Notified Body review.
- Intended use vs. actual use: Regulators emphasize that even if marketed as “wellness” tools, apps used in medical contexts may be reclassified as medical devices.
Key requirements for compliance
- Technical documentation: Technical documentation must include product description, intended use, design, risk analysis (ISO 14971), cybersecurity measures, and usability validation.
- Clinical evaluation: Evidence of safety and performance through clinical data, literature, or trials. AI-based tools must show transparency and explainability.
- Quality management system (QMS): ISO 13485-compliant QMS is mandatory for design, development, and post-market surveillance.
- Post-market surveillance: Continuous monitoring, incident reporting, and periodic safety updates are required.
- Interoperability and data protection: Secure handling of patient data is essential.
- Notified body assessment: Higher-risk software must undergo independent review before CE marking.
Challenges for digital health developers
- Classification ambiguity: Many apps can be classified as intended for wellness and medical use, thereby creating regulatory uncertainty.
- AI transparency: MDR requires explainability of algorithms, which is difficult for complex machine learning models.
- Cybersecurity obligations: Digital health tools must demonstrate resilience against cyber threats.
- Resource burden: Small developers face high costs for QMS, clinical validation, and audits.
Thus, a software will be treated as a medical device if it influences diagnosis, monitoring, or treatment. Documentation, clinical evidence, and ongoing surveillance are critical pillars of compliance. Furthermore, CE marking under MDR is mandatory for digital health technologies with medical claims.
Why is CE marking mandatory?
- Legal requirement: Under the EU Medical Device Regulation (MDR 2017), any digital health technology that qualifies as a medical device or diagnostic tool must carry CE marking before being marketed in the EU/EEA.
- Market access: CE marking of digital health technologies is mandatory for free circulation of products across EU member states without additional national approvals.
- Patient safety and trust: It assures regulators, clinicians, and patients that the technology meets essential safety, performance, and quality standards.
What digital health technologies do CE marking apply to?
- Medical software and apps: Clinical decision support, diagnostic imaging software, symptom checkers.
- Wearables and sensors: Smartwatches with ECG, glucose monitors, connected inhalers.
- AI tools: Algorithms for radiology, pathology, or predictive analytics.
- Electronic health records (EHRs): Under the new European Health Data Space (EHDS) regulation, EHR systems must also be CE marked.
7 Steps for obtain CE marking of digital health technologies
We have provided a step-by-step guide to obtaining CE marking for digital technologies.
- Classification: Determine if the product qualifies as a medical device or IVD. Software with diagnostic/therapeutic claims is usually Class IIa or higher.
- Quality management system (QMS): Implement ISO 13485-compliant QMS covering design, risk management, and post-market surveillance.
- Technical documentation: Prepare a dossier including intended use, design, risk analysis (ISO 14971), cybersecurity, usability validation, and clinical evaluation.
- Clinical evaluation: Provide evidence of safety and performance through trials, literature, or real-world data.
- Notified body review: Independent audit and certification for Class IIa and above will be required.
- Declaration of conformity: Manufacturer signs a legal statement (declaration of conformity) confirming compliance.
- Post-market surveillance: Ongoing monitoring, incident reporting, and periodic safety updates will be required for digital health technologies.
Therefore, CE marking of digital health technologies is vital for patient safety, clinical reliability, and market access in the European Union. By warranting rigorous classification, technical documentation, clinical validation, and ongoing post‑market surveillance, the MDR ensures that software, apps, wearables, and AI‑driven tools meet the highest standards of quality and performance. Having the CE marking demonstrates a commitment to transparency, data protection, and continuous improvement. Thus, CE marking transforms digital health technologies into legally recognized, safe, and effective solutions that can be confidently integrated into healthcare systems across Europe. Drop an email at [email protected] or call/Whatsapp on 9996859227 to easily secure CE marking for your digital health technology.
