Conformity assessment for Class III custom made implantable

kreid

Involved In Discussions
Hello, does a company providing Class III, custom made 3D printed implantable devices need certified proof of conformity assessment to EU MDR by a notified body?
 

Raisin picker

Quite Involved in Discussions
First, see MDR Article 2(3), if your device meets the definition of custom-made device. Then take a look at Article 52(8).
 

kreid

Involved In Discussions
First, see MDR Article 2(3), if your device meets the definition of custom-made device. Then take a look at Article 52(8).
Yes, thanks, Art 53 points to Annex XIII which says that the Manufacturer shall make a statement with specific contents.
So there is no external assessment before provision of the product to the end customer
 

Raisin picker

Quite Involved in Discussions
I seem to have a different copy of the MDR:
Article 52:
8. Manufacturers of custom-made devices shall follow the procedure set out in Annex XIII and draw up the statement set out in Section 1 of that Annex before placing such devices on the market.

In addition to the procedure applicable pursuant to the first subparagraph, manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment as specified in Chapter I of Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Part A of Annex XI.
 
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