Purpose and Scope
The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). The document was developed by reviewing the application process and associated documents of individual Team-NB members and harmonising the processes where possible.
This document is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before.
The document also briefly describes the certification activities that are undertaken after the application process is concluded.
This consensus guidance document is aligned to the requirements of Medical Devices Regulation [MDR] (EU) 2017/745, described in detail in Annex VII §4.2, §4.3 for pre-application and application requirements.
The following are outside the scope of this document:
– Application process for a NB certificate as per Article 16 of MDR.
– Application process for a NB opinion for devices as per Article 117 of MDR.
– Application process for Recertification as per Annex VII §4.11 of MDR.