How to market a custom-made medical device? (EU MDR 2017/745)

[@EasyMedicalDevice]

I wish this video will provide you with some great information to support your learning journey to MDR 2017/745

[@francescodisimone7754]

Really thank you for this video. I'm working now in a startup that wants make custom made cranioplasty based on 3d scan of patient. Reading MDR seems that i need just follo annex XIII but it seems really too easy...no technical dossier, no clinical validation, no mechanical validation...how is it possibile? Dont i need to release conformity? Is it just self-declaration like MDD? The only difference that i have found is post-market survelliance

[@EasyMedicalDevice]

Hi Francesco. The difficulty with custom made is that you need to build a mini-dossier for each release. And in some countries you need to register each product launched. I hope you‘ll succeed

[@francescodisimone7754]

@@EasyMedicalDevice i suppose that concerning custom made class II b, this mini-dossier it's not ANNEX II of MDR, becouse it's not required for custom device IIb...right? ;) Sorry for my ignorance but worked only in R&D department.

[@knowldge2760]

Can you provide list of documents required custom made device as EUMDR guidelines

[@Verbena369]

Thank you so much for such helpful information sharing ! May I know the customized product still requires EU Rep ? What's the difference between EU Rep and PRRC?

[@EasyMedicalDevice]

Hi, Thanks. Yes, the Custom-made product needs an EU REP to represent the company in case this one is not in Europe. A PRRC is a person that has the Qualification to help you with your Quality and Regulatory affairs. I think I have another video on that

[@Verbena369]

Thank you for the quick reply!🙏

[@szormoks]

Hello, what do you think, does custom made medical device's manufacturer need to make clinical evaluation or not? Thank you.

[@EasyMedicalDevice]

Hi, Yes custom made device need a Clinical Evaluation. And if this is not sufficient even a Clinical Investigation for Class III devices. I had the case with a Custom-made Knee implant Class III manufacturer who had an audit and the auditor asked them to see the Clinical Investigation for its product but we were able to demonstrate that a Clinical Evaluation is sufficient.