Introduction
As digital healthcare solutions evolve, Software as a Medical Device (SaMD) has become a crucial innovation in modern medicine. Whether it’s a diagnostic app, AI-based imaging software, or a remote monitoring tool, if you’re planning to launch SaMD in the European Union (EU)—particularly in the Netherlands—you need to ensure CE Marking compliance.
In this blog, we’ll break down what CE Marking means for SaMD, the regulatory steps involved, and how to bring your medical software to market in the Netherlands smoothly and compliantly.
What is CE Marking?
CE Marking is a certification mark that confirms a product’s compliance with EU safety, health, and environmental protection standards. For medical devices, including SaMD, it indicates that the product meets the Medical Device Regulation (EU) 2017/745 (MDR) requirements.
Without CE Marking, you cannot legally market or sell your medical device in the EU, including the Netherlands.
What is Software as a Medical Device (SaMD)?
Software as a Medical Device refers to software that is intended to be used for medical purposes without being part of a hardware medical device. This includes software that:
- Diagnoses or monitors a medical condition
- Provides therapy recommendations
- Analyses or processes medical images or patient data
If your software performs any medical function, it likely qualifies as SaMD under the EU MDR and must go through the CE Marking process.
Why CE Marking Matters for SaMD in the Netherlands
The Netherlands is a hub for digital health startups and medical technology innovation. However, to gain market access, manufacturers must navigate strict regulatory pathways.
CE Marking for SaMD ensures:
- Legal market entry in the Netherlands and across the EU
- Increased trust from healthcare providers and users
- Reduced legal and financial risks
CE Marking Process for Software as a Medical Device (SaMD)
1. Determine Classification Under EU MDR
Under MDR, SaMD is classified based on risk level into Class I, IIa, IIb, or III. Most SaMDs fall under Class IIa or higher, requiring Notified Body involvement.
2. Define the Intended Use and Claims
Clearly define the intended use, target users, and medical claims of your software. This forms the basis for classification, clinical evaluation, and labeling.
3. Conduct a Clinical Evaluation
Prepare a Clinical Evaluation Report (CER) using clinical data, literature reviews, and/or studies demonstrating safety and performance of the software.
4. Implement a Quality Management System (QMS)
CE Marking for SaMD requires a robust QMS such as ISO 13485 to manage development, risk, and post-market surveillance.
5. Perform Risk Management
Conduct risk analysis in accordance with ISO 14971, identifying potential hazards, evaluating risks, and implementing control measures.
6. Technical Documentation Preparation
Compile comprehensive technical documentation that includes:
- Software design and architecture
- Cybersecurity measures
- Verification and validation data
- Labeling and Instructions for Use (IFU)
7. Appoint an EU Authorized Representative (If Outside the EU)
Non-EU manufacturers must appoint a Dutch or EU-based Authorized Representative to act as a legal liaison with EU regulatory authorities.
8. Involve a Notified Body (If Applicable)
For Class IIa and higher SaMDs, submit your technical file to a Notified Body for review and conformity assessment.
9. Declaration of Conformity & Affix CE Mark
Once your product complies with all relevant requirements, issue a Declaration of Conformity (DoC) and affix the CE Mark on your software product and documentation.
Post-Market Requirements in the Netherlands
After obtaining CE Marking, you must comply with ongoing post-market surveillance, including:
- Periodic Safety Update Reports (PSUR)
- Vigilance reporting
- Software updates and change control documentation
- User feedback and complaints management
Common Challenges in CE Marking for SaMD
- Interpreting MDR classification rules for software
- Demonstrating clinical performance without physical interaction
- Keeping up with evolving cybersecurity and AI/ML regulations
- Managing frequent software updates and change control
Working with a regulatory consultant experienced in CE Marking for SaMD in the Netherlands can help you navigate these complexities.
How Operon Strategist Can Help
At Operon Strategist, we specialize in guiding SaMD manufacturers through the CE Marking process, ensuring compliance with MDR and smooth market entry in the Netherlands and across the EU.
Our services include:
- SaMD classification and regulatory strategy
- Technical file and QMS documentation
- Clinical evaluation support
- Notified Body coordination
- Post-market compliance assistance
If you’re ready to start the CE Marking process for your SaMD, contact our experts for end-to-end regulatory support.