Is a Dental Laboratory Device a Medical Device?

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Is a Dental Laboratory Device a Medical Device?

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19th May 2012, 05:32 AM

w_grunfeld w_grunfeld is offline

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Re: Is a Dental Laboratory Device a Medical Device?

The "problem" is it's such a simple mechanical device -a holder with an articulation.....that running the ISO 14971 on it would amount to fill out lots of tables/checklists with N/A
If I'd classify the device according to MDD annex IX most likely it will turn out not being a medical device at all. If it is according to some interpretations , it's class I by default

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Is a Dental Laboratory Device a Medical Device?

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