In the Directive on Medical Models, the medical system is classed in accordance with the provisions of Annex IX of the MDD as class I (low danger), class IIa or IIb (medium hazard) or class III (excessive hazard). The involvement of a Notified Body is just not obligatory for medical items of class I until they have a measuring function or are positioned on the market in a sterile situation. It’s important to hunt the advice of the Directive to ensure that the product complies with the entire essential requirements.
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