Posted By
Jos Kraus
15-Jan-2020 05:17
Found In
Egroup:
Regulatory Open Forum
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Does the robot change or interfere with the products? Hopefully not. Therefor it's not an IVD or MD (based on EU law) but a general product which has to comply with a even more stringent EU law The general product saftey regulations which demands absolute safety and benefit/risk approach is not allowed. ...
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