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Different experiences around the world on institutional or governmental validation
My experiences have mainly been in Asia (Hong Kong, Singapore and Australia) but it seems to me that most countries experience the same issue but I would like to know more about the following.
What are your experiences in doing 3D printing for medical interventions from a health authority perspective? Are there any places where 3D printed parts can be used in a routine way with the same approval processes as you might find for a standard implant, template, device, etc?
76 months ago
2 answers
To the best of my knowledge the FDA has just released "final guidance for additive and 3D printed medical device manufacturers in Dec 2017. To the best of my knowledge I am unaware of comparable guidance from Health Canada on the device side. I believe the Canadian hospitals are currently dealing with this through professional liability insurance.
Terry Sullivan
76 months ago
In Europe, printing devices in general are subject to so called horisontal rules of product placement on the market ("CE marking") and some other more specific rules like Radio Equipment Directive (for example in case of WiFi connectivity). Placement on the market is possible by self-declaring against harmonised European standards that the product complies with them. In this case, there could be applicable also Medical Device Regulation (as it could be about implants), which is about the same as above mentioned but in particular for medical devices or devices that could be considered partially or whole as medical. Machinery Directive could apply in case of more complex devices. For more details, it would be necessary to see more specifics about the device itself, primary purpose, any secondary purpose etc to exactly determine according to which rules it should be placed and operated on the market.
76 months ago
