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Patrick González on the RSP and the MDR roadmap

22 February 2023
Medical device development expert Patrick González talks about the Faculty of Science's new Research Support Portal, and the importance of the Medical Device Regulation roadmap for all STEM researchers.

What is the Research Support Portal?

"The Research Support Portal (RSP) is the starting point for all researchers, from students to professors, but it is also very useful for project supporters. You can find all the information regarding research and support services here. From legal support and regulations to safety issues. You will also find information on grants, spin-offs - you name it. The RSP is divided into three phases: preparation, execution and completion of your research. So at each stage of your research, you have all the relevant information together in one overview."

What kind of investigations is the portal for?

"Actually, it's always good to start with the RSP. In many cases, you work with data and have to hand over a research data plan before you even start your research. There are also privacy rules you need to think about. Or maybe there is a grant application for which you need certain support. In other cases, you need a lawyer . For example, contracts for consortia with international partners. You can also overcome risks in the field of security or finance at an early stage. It is important to know these things in time, so you can call in the right support. For each topic, we have colleagues with the right expertise who are willing to think along."

With the launch of the new portal, Patrick González developed the Medical Device Regulation (MDR) page and a roadmap. As a medical device development expert at the Faculty of Science, he knows better than anyone else what is involved in these regulations. Why was this roadmap developed?

"The Medical Device Regulation is a European regulation that came into force 1 May 2021 and regulates the conduct of clinical research on medical devices. A medical device can be hardware, for example a CT scanner, or a hypodermic needle, but also software, such as a diagnostic AI model, can be a medical device within the new legislation. So if you develop a medical device and want to conduct clinical research, you are bound by new rules. These are mainly intended for manufacturers who want to bring a device to the market, but even researchers may have to deal with them if they do clinical research."

"With the MDR roadmap, you check whether the new regulations apply to your research. The roadmap will then help you find the right information and support so that you are little affected by the regulations during your research."