How to Use MDR Navigator:
An Informational Assistant for Navigating the MDR, IVDR and MDCG Guidance Documents
Introduction
MDR Navigator is a specialised GPT, published in November 2023, designed to help professionals and stakeholders in the medical device sector navigate the European regulatory framework.
It can support the consultation and understanding of Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), and the main related documents, including guidance published by the Medical Device Coordination Group (MDCG).
Try the Demo on the Website
To quickly see how MDR Navigator works, open the “Ask MDR Navigator” widget in the bottom-right corner of the website. The demo allows you to select a number of introductory questions and immediately view a brief answer.
To explore one of the proposed topics in greater detail or ask a different question, select:
Explore with MDR Navigator → You will be redirected to the full version of MDR Navigator available on ChatGPT.
How to Access MDR Navigator
You can open MDR Navigator directly using the button on this page or the link available within the widget “Ask MDR Navigator”.
You may need to sign in to your ChatGPT account before starting the conversation.
There is therefore no need to search for MDR Navigator manually in the GPT Store.
Tips for Formulating Effective Questions
To obtain more relevant and useful answers, it is important to formulate requests clearly and provide sufficient context.
- Be Specific
When asking a question, try to be as specific as possible about the context and the topic you want to explore. Avoid general questions such as: “How can I comply with the MDR?” Use a more detailed question instead, for example: “What are the specific technical documentation requirements for a class IIa medical device under Regulation (EU) 2017/745?” - Provide Context
Include details that may help clarify the situation, such as the type of device, intended purpose, risk class, and the specific requirement you want to examine.
Additional information helps generate more focused and relevant answers. - Use Relevant Keywords
Using regulatory keywords related to your question can make it easier to identify relevant information. For example, when asking about the preparation of a PSUR (Periodic Safety Update Report), include terms such as: ‘PSUR’, ‘MDR 2017/745’, ‘Article 86’, type of medical device and its risk class. This approach helps narrow the request and obtain a response that is more relevant to the situation described. - Avoid Ambiguous Wording
Formulate the question clearly and avoid vague terms that could be interpreted in different ways. A precise request reduces the risk of misunderstanding and increases the likelihood of receiving an appropriate answer. - Break Down Complex Requests
When several topics need to be addressed, it may be helpful to divide the request into separate questions or list the points in order of priority. This makes the conversation easier to follow and allows each aspect to be explored individually.
Benefits of Using MDR Navigator
- Initial Guidance on Potentially Applicable Requirements
MDR Navigator can help identify articles, annexes, definitions, and documents that may be relevant to the question submitted. It does not replace a regulatory assessment, but it can provide a useful starting point for organising research or exploring a particular topic. - Easier Consultation
The MDR, IVDR, and MDCG guidance documents include numerous requirements and cross-references between different sources.
MDR Navigator allows users to ask questions in natural language and receive structured answers, making it easier to identify the aspects that should be verified and explored further using official sources. - Time Savings During Preliminary Research
Manually searching through regulations, annexes, and guidance documents can be time-consuming.
MDR Navigator can help to: identify possible regulatory references; compare related concepts; summarise a topic; create an initial list of points to verify. - Ability to Continue and Deepen the Conversation
After receiving an initial answer, you can continue the conversation by asking for: further details; practical examples; differences between requirements; references to verify; a shorter summary; clarification of a specific point.
Answers should always be verified against the specific circumstances and the current version of the applicable official sources.
Limitations of the Tool
MDR Navigator is an artificial intelligence-based tool and may: misinterpret a question; provide incomplete information; confuse requirements applicable to different situations; indicate references that are not relevant or up to date; generate answers that require further verification.
The quality of the result also depends on the clarity, accuracy, and context of the question submitted.
Do not enter personal information, confidential data, trade secrets, or confidential company documentation into the conversation unless you have first assessed the terms and conditions applicable to the service being used.
Feedback and Improvements
MDR Navigator is periodically updated and refined through the review of its instructions, content, and feedback received.
Comments, reports, and suggestions can help identify: topics that should be explored further; answers that could be improved; new frequently asked questions; features that could make the tool more useful; possible errors or references that should be corrected.
You can send your feedback to: info@simoneronco.com
Disclaimer
MDR Navigator and ChatGPT are artificial intelligence-based tools and are subject to changes and updates. Generated answers may contain errors, omissions, incorrect interpretations, or outdated information.
The content provided is for informational purposes only and does not constitute legal, regulatory, technical, clinical, or professional advice.
Before making decisions relating to the qualification, classification, conformity, registration, post-market surveillance, or placing on the market of a device, the information should be verified against the applicable official sources and assessed in light of the specific circumstances.
Where appropriate, advice should be obtained from a qualified professional or from the relevant authorities and competent bodies.