how to obtain CE mark for medical device
AI Search Visibility Analysis
Analyze how brands appear across multiple AI search platforms for a specific prompt
Total Mentions
Total number of times a brand appears
across all AI platforms for this prompt
Platform Presence
Number of AI platforms where the brand
was mentioned for this prompt
Linkbacks
Number of times brand website was
linked in AI responses
Sentiment
Overall emotional tone when brand is
mentioned (Positive/Neutral/Negative)
Brand Performance Across AI Platforms
Strategic Insights & Recommendations
Dominant Brand
No specific brands are prominently featured, as both platforms focus on regulatory processes and standards like ISO 13485 and EU MDR compliance.
Platform Gap
ChatGPT provides more structured step-by-step guidance while Perplexity offers more context about timeframes and complexity, with Google AIO providing no response.
Link Opportunity
Both platforms reference multiple consulting firms and regulatory guidance websites, indicating opportunities for specialized CE marking consultation services.
Key Takeaways for This Prompt
CE marking requires compliance with EU MDR 2017/745 and involves device classification into risk classes I-III.
Higher-risk devices (Class IIa, IIb, III) require notified body assessment while some Class I devices can self-certify.
Quality management systems aligned with ISO 13485 and comprehensive technical documentation are mandatory.
The process can take several months to over a year depending on device complexity and classification.
AI Search Engine Responses
Compare how different AI search engines respond to this query
ChatGPT
SUMMARY
ChatGPT provides a comprehensive 11-step guide for obtaining CE marking for medical devices under EU MDR 2017/745. The response covers device classification (Class I-III), quality management system implementation, technical documentation preparation, clinical evaluation, notified body engagement for higher-risk devices, and post-market surveillance requirements. It emphasizes the importance of appointing a Person Responsible for Regulatory Compliance and registering devices in EUDAMED with UDI assignment.
REFERENCES (5)
Perplexity
SUMMARY
Perplexity offers a detailed 10-step process for CE marking medical devices, emphasizing the structured approach required for EU MDR compliance. The response covers device classification, QMS implementation aligned with ISO 13485, technical documentation preparation, clinical evaluation with CER, European Authorized Representative appointment, conformity assessment procedures varying by device class, and EUDAMED registration. It notes the process complexity and typical timeframes of several months to over a year.
REFERENCES (8)
Google AIO
SUMMARY
No summary available.
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