Create your intended purpose with Cesare Magri (Medical Device)

As Cesare Magri said, the intended purpose is not really a priority for some companies so they don’t take to much time to write them. But you will hear in this episode why it is clearly a strategic task for your company.

When you are creating your EU MDR 2017/745 technical documentation, you have to also define some scope for your product. And it is the objective of the intended purpose.

Cesare Magri from be-on-Clinical (which is related to be-on-Quality) is helping companies and he sees a lot of examples of issues related to the intended purpose. He will share with us the different steps needed to build your intended purpose and he will offer also a document to download that can be used to brainstorm regarding your intended purpose with your team.

Who is Cesare Magri?

Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. Recently he founded be-on-Clinical together with Stefan Bolleininger in 2020.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…


Episode 65 - Create your intended purpose with Monir El Azzouzi and Cesare Magri from be on Clinical - Easy Medical Device

4 Replies to “Create your intended purpose with Cesare Magri (Medical Device)”

  1. Nigel Scotland

    Hi Monir, this podcast was really helpful especially when stressing about the importance of the general description and its intended purpose due to the fact that the auditor would not go any further with the submission if this part was lacking in detail. Just copying and pasting the product description from marketing brochures or the company website would not make it through. Your podcast provided some excellent resources.

  2. Carlo Massini

    Hi Monir, thank you very much for this very useful podcast: I’m working just now on the Intended Purpose for some IVD products (according to 2017/746/EU).
    May I have a clarification? In the case of IVDs that are just for quantification of an analyte in a population without any link to specific pathology, is sufficent to write the Intended Purpose as follow: “the quantification of the to evaluate its concentration in human healthy subjects”? (I avoid to list now specimen or other details in my question).
    Thanks for your work!

    • Cesare Magri

      Yes you can explicitly clarify that. Probably for your device the section “contraindication” will be important instead, if you want to explicitly exclude pathologies with which your device should not be used. Also note that for IVD you also have to have the sample specification in addition to the patient specifications.

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