Other questions and answers under organizational and general requirements relate to the meaning of the terms “legal personality,” “organization” and “organizational structure” under MDR/IVDR, as well as the clearance of consultants per Regulation (EU) 920/2013, pre-certification services, new conditions on remuneration, absence of conflict of interests declarations and evidence of individual liability insurance.
The MDCG emphazises that a NB cannot accept any application under MDR or IVDR before a designation becomes valid on the day after the notification is published in the EC’s NB database, known as NANDO.
RAPS: Regulatory News
European Commission: DocsRoom
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