How to comply to the GSPR ? (EU MDR and IVDR - Monir El Azzouzi)

[@EasyMedicalDevice]

Don't forget to download the presentation from the show notes.

[@ashleyreynoldsschneider3839]

This is really helpful.

[@bredakearney3388]

Very informative video - Thanks for sharing

[@EasyMedicalDevice]

Thanks breda. Really appreciated

[@ceciliarourke5738]

Where to next for the medical device industry?

[@YoganandM-w2z]

Hi Mounir, Thanks for the video. May i know the purpose of GSPR in Annex II (Technical Documentation). How much it is different from Annex 1 GSPR

[@EasyMedicalDevice]

Hi Yoganand, thanks for your message. The annex II is for the creation of the Technical File. GSPR is just mentioned inside as a reference. So when you complete the GSPR annex I, you will have to include it in the Technical Documentation.

[@qualitycontrol926]

Would the GSPR apply to PPE and replace the Essential Health and Safety Requirements??

[@brindhakct4717]

How do I attend this kind of live session?

[@voomdirect1952]

Hello Monir, I am planning to distribute first aid kits in US and EU, i am stuck with complying with labeling and packaging my product, can you advise me about this. In particular how should the label be attached to the package, how should this be done? Can you direct me to a video or link advising to this? Thankyou

[@EasyMedicalDevice]

Hi, thanks for your message. Is your product a kit that contains already approved products or is it you who will produce each item?
For the label requirements, it is on chapter 3 of the GSPR. This video is talking about it

[@discoverafrica7524]

Thanks Mounir
Training courses in Risk Management process of Medical devices: Gestion des risques des dispositifs médicaux | Udemy