Amendment: Re-assessment frequency of notified bodies (Reg 2017/745)

This procedure updates the rules regarding how often 'notified bodies'—the organizations responsible for assessing the compliance of medical devices—must undergo a full re-assessment. This ensures that the bodies certifying medical products maintain high standards of quality and safety to protect public health.

This change primarily affects the notified bodies that certify medical devices and the manufacturers who rely on their certifications for market access.