U opšta medicinska sredstva spadaju pomoćna sredstva koja po definiciji nisu medicinsko sredstvo, a koja označavaju proizvode koji u kombinaciji s medicinskim sredstvom omogućavaju funkcionisanje u skladu sa njihovom namenom koju određuje proizvođač

Medical device accessories are products used in tandem with other medical devices, known as “parent devices,” but are sometimes (not always) regulated as separate devices
The manufacturer, in preparing for CE marking, should first determine if their product falls within the scope of the Directive or national Regulation, either as a medical device or as an accessory to a medical device, as defined in Article 1 of Directive 93/42/EEC and Article 2 of the Regulation

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