How System and Procedure Pack are regulated under EU MDR?

Medical Device made Easy Podcast · Mar 16, 2021

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Let’s discuss System and Procedure Pack. We usually talk about medical devices like as an object that is used in the healthcare industry. But when you have to combine multiple objects, how can you then regulate that. Is there one classification for all or should you classify and register each of them. And what if all these objects are already CE marked?

So this episode will try to help you understand the legislation for these types of products described in article 22 of the EU MDR 2017/745 regulation on system and procedure pack. We will also mention the KITS that are…