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What rules should be applied to 3D printed - patient specific products?

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Guest user Created:   Apr 19, 2022 Last commented:   Apr 19, 2022

What rules should be applied to 3D printed - patient specific products?

What rules should be applied to 3D printed - patient specific products (we understand that 3D product is not under custom made according to MDR, should be CE marked - but labeling should contain patient data as custom made product). This is not serial or custom, is in the middle - patient specific - missing term and conditions in MDR. We have to put CE on our products and DoC (we declare conformity of the process) - but finally the clinician should provide declaration based on individual paient´s data?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 19, 2022

The biggest question here is what is the intended purpose of the device. Depending on the purpose of the product, and thus the classification of the product, it depends on whether it is necessary to put the CE mark on the product and what documentation needs to be prepared.

Only implantable and Class III custom-made products require the affixing of the CE mark and the inclusion of a Notify body in the whole process. For all other classes, it is sufficient to prepare technical documentation for the product as described in Annex 13.

For more information, see:

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Apr 19, 2022

Apr 19, 2022