MDR Navigator
By Simone Ronco
Guide to using the Chatbot dedicated to the MDR and IVDR regulations
Introduction
MDR Navigator, released in November 2023 on the OpenAI GPT Store, is the first chatbot based on GPT technology (Generative Pre-trained Transformer) designed to provide detailed information on the European Union’s Medical Devices Regulation (MDR) 2017/745, the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746, and related EU documents, such as the guidelines of the Medical Device Coordination Group (MDCG).
Access and First Steps
To use MDR Navigator, first, you need to log in to your ChatGPT account.
The video below describes the following steps:
- In your account dashboard, click on the menu on the left on “Explore GPTs” and type in the search bar: “MDR Navigator”.
- After selecting the chatbot, it will open in a new page, and you can start using it immediately.
- To add it to the sidebar menu of your dashboard, along with your favorite GPTs, click on the dropdown menu at the top under “MDR Navigator” and select the option “Keep in sidebar”.
Tips on How to Ask Questions
Here are five useful tips on how to ask questions effectively to get the most accurate and helpful information from MDR Navigator:
- Be Specific
When you ask a question, try to be as specific as possible about the context and the topic of interest. Avoid generic questions like “How can I comply with the MDR?” and prefer detailed queries, for example: “What are the specific requirements for the technical documentation of a Class IIa medical device according to the MDR Regulation 2017/745?” - Provide Context
Include relevant details that can better clarify your situation, such as the type of medical device, risk class, or specific requests. Additional information helps to obtain more targeted and relevant answers. - Use Relevant Keywords
Using relevant keywords related to your question facilitates the identification of relevant information. To illustrate, for questions on compiling the PSUR (Periodic Safety Update Report), include specific terms like ‘PSUR’, ‘MDR 2017/745’, ‘Article 86’, the type of medical device, and its risk class. This approach helps narrow down the search to the most relevant and accurate information for your situation. - Avoid Ambiguity
Ensure that your question is formulated clearly, avoiding vague terms that could lead to multiple interpretations. A precise question reduces the risk of misunderstandings and increases the chances of getting an appropriate answer. Remember, MDR Navigator is a chatbot specifically designed for MDR and IVDR regulations. - Prioritize Questions
If you have multiple issues, listing them in order of priority or grouping them by theme can better organize the conversation, ensuring that the most relevant questions are addressed first.
Benefits of Using MDR Navigator
Using MDR Navigator as a chatbot assistant to clarify doubts about MDR and IVDR regulations offers several significant benefits for professionals in the medical device industry. Specifically, the main benefits include:
- Direct Access to Updated Information
MDR Navigator provides direct and timely access to the latest information and updates on European medical device regulations.
- Ease of Use and Continuous Learning
Users can easily integrate MDR Navigator into their ChatGPT dashboard, avoiding the need to switch between different platforms or tools. Moreover, thanks to continuous user interaction, the chatbot has the potential to improve over time, providing increasingly accurate and detailed answers.
- Time and Resource Savings
Searching for information among relevant regulations and guidelines can be a long and complex process. MDR Navigator significantly simplifies this process, allowing users to quickly find the specific answers they need. This results in considerable time and resource savings that would otherwise be spent on manual search through various documents and sources.
Feedback and Improvements
In conclusion, receiving feedback after use is essential as it allows for the continuous improvement of MDR Navigator. For example, if you have suggestions, comments, or ideas on how the chatbot can be improved to be even more effective and useful, you can send your feedback directly to the email address: info@simoneronco.com.
Disclaimer
Both MDR Navigator and ChatGPT are currently under development and subject to constant updates; as a result, they may generate errors. The information provided through these tools is intended for informational purposes only and is not meant to serve as consultancy. It is essential to consult with a professional expert in medical devices to ensure that decisions made are based on accurate information and comply with applicable regulations, thereby specifically addressing the user’s needs.