how to obtain CE mark for medical device
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AI Search Engine Responses
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ChatGPT
BRAND (23)
SUMMARY
Provides a structured step-by-step guide to obtaining CE marking for medical devices in the EU, starting with device classification under MDR 2017/745. Explains the four risk classes (I, IIa, IIb, III) and emphasizes that classification determines the level of scrutiny and conformity assessment procedures required. References Deloitte as a source for additional guidance.
REFERENCES (4)
Perplexity
BRAND (23)
SUMMARY
Offers a comprehensive overview of the CE marking process, explaining it as structured compliance with EU regulations for EEA market access. Covers device classification under both MDR 2017/745 and IVDR 2017/746, providing specific examples for each risk class. Emphasizes the importance of intended purpose, risk profile, mode of action, and design characteristics in classification.
REFERENCES (15)
Google AIO
BRAND (23)
SUMMARY
Presents a concise, process-oriented approach focusing on key steps: device classification, QMS implementation, technical documentation preparation, Notified Body involvement for higher-risk devices, Declaration of Conformity issuance, EUDAMED registration with UDI, and CE mark affixing. Organizes information into clear preparation, compliance, assessment, and final steps.
REFERENCES (10)
Strategic Insights & Recommendations
Dominant Brand
SGS appears as the most mentioned brand with 6 references, while Deloitte is also notable with 4 mentions in the ChatGPT response.
Platform Gap
ChatGPT provides detailed regulatory context, Perplexity offers comprehensive classification examples, while Google AIO focuses on practical implementation steps.
Link Opportunity
All platforms provide substantial link opportunities with ChatGPT offering 4 links, Google AIO 10 links, and Perplexity 15 links for additional resources.
Key Takeaways for This Prompt
Device classification under EU MDR 2017/745 is the critical first step that determines all subsequent requirements.
All platforms emphasize the four-tier risk classification system (Class I through III) as fundamental to the process.
Quality Management System implementation and technical documentation are universally highlighted as essential requirements.
Notified Body involvement is consistently mentioned as necessary for higher-risk device categories.
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