14 January 2025

Position Paper of Team NB adopted: MDR Certification Process (including Pre-application, Application and Post Application phases)

Certifying medical devices under the MDR involves several steps, necessitating careful preparation and close cooperation with Notified Bodies. These steps can pose significant challenges to manufacturers, particularly during the application phase, where they seek certification from NBs in accordance with the regulation (EU) 2017/745 (MDR). 

 

TEAM -NB, The European Association Medical devices of Notified Bodies, established a task force to laid down a common paper aimed to establish a common understanding and minimise the number of incomplete submissions received by the NBs during the application phase process, which to date seem to be the main reasons for the delays and failures recorded. The Position Paper “MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document” was adopted by the Team NB members and published on December 18th 2024.  

 

This Position Paper 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 and is aligned to the requirements of MDR, described in detail in Annex VII §4.2, §4.3 for pre-application and application requirements. However, be aware that 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. 

The document provides a clear description of the pre-application and application processes, detailing the minimum or typical information and data manufacturers need to submit to apply for certification from Notified Bodies (NBs) under the MDR. Additionally, it offers a brief overview of the certification activities carried out after the application process, referred to as the "post-application phases." 

The phases are clearly outlined and can be easily grasped through the summarized stages presented in the flow below. 

MDR Certification Process.png

 

Focusing on pre-application and application phase, we would like to underline the following steps

  • Initial contact & pre-application submission: Initiate contact with the Notified Body to request conformity assessment services. During this step, manufacturers need to provide crucial information about the device, its classification, and the certification scope. Providing comprehensive and accurate details helps minimize delays and allows the NB to prepare a detailed quotation efficiently.;
  • Pre-application review and quotation process: NB conducts an initial review to verify that the device meets MDR requirements and is accurately classified. Following this review, the NB prepares a quotation for the conformity assessment services.;
  • Formal application lodging: After the manufacturer signs and accepts the quotation, they must formally submit their application, including the required documentation specified in Annex IX or XI of the MDR. This includes the Quality Management System (QMS) documentation, as well as technical and clinical documentation relevant to the device's classification. If the manufacturer has already received the contract template and the terms and conditions along with the quotation, they should also submit the signed contract along with the application documents.;
  • Contract/Written agreement and application review: Once the application is submitted, if not previously provided, the Notified Body (NB) will issue the contract documents to the manufacturer for signing. After the contract is signed, the NB will proceed with the application review based on the submitted documentation. Depending on the outcome of this review, the NB will decide whether to accept or refuse the application. Any refusals will be communicated through EUDAMED (or other means if EUDAMED is not in use).

 

The Team-NB consensus document provides an extensive overview of the MDR certification process for medical devices. Its organized structure and clear guidelines help manufacturers work effectively with Notified Bodies, reducing errors and delays, and ensuring a streamlined certification process.

Our Kiwa Team can help you to understand in deeper all these phases. Don’t hesitate to contact us for a structured dialogues on this matter trough medical@kiwa.com .