Team NB Releases Document on the MDR Certification Process

Team NB has released a new document titled “MDR Certification Process (including Pre-application, Application, and Post-application Phases) – Consensus Document.”

This document aims to provide detailed guidance on the pre-application and application processes for manufacturers seeking certification of medical devices under the EU Medical Devices Regulation (MDR) 2017/745.

Key points include:

• • Describing the processes for applying to Notified Bodies (NBs) for device certification under Regulation (EU) 2017/745 (MDR).
  • Providing guidance that is harmonized with the application processes of individual Team NB members.
  • Offering detailed information about the required documentation for formal application, conformity assessment, and surveillance activities to maintain the certificates issued after certification.

Scope of the MDR Certification Process

• • Applicable to both legacy devices transitioning to MDR (Article 120) and new market devices not previously certified under the Directives.
  • Briefly covers post-application certification activities.

Link to the full document can be found here: All News – Welcome to Team NB | Team NB

For guidance on navigating evolving regulations, contact us today.