Team-NB Guide December 2024: Your Complete Resource for Medical Device Certification
On December 18th, 2024, Team-NB, the European Association of Medical Device Notified Bodies, released an important guide for manufacturers seeking medical device certification under the EU Medical Device Regulation (MDR 2017/745). This publication provides clear and actionable guidance on the certification process for medical devices, ensuring compliance with European standards.
Why the Team-NB Guide is Crucial for Medical Device Manufacturers
This Team-NB guide is an essential resource for medical device manufacturers, whether they are introducing new devices to the European market or transitioning legacy devices to the new regulation. By following the comprehensive steps outlined in the document, manufacturers can streamline the process of obtaining certification, ensuring their devices meet all the necessary legal and regulatory requirements.
Step-by-Step Guide to Medical Device Certification
The Team-NB guide covers each phase of the medical device certification process, from initial preparation to post-certification surveillance:
- Pre-application and Quotation: The first step involves gathering preliminary data to assess the device’s classification and determine the required documentation. Manufacturers are advised to consult with a Notified Body (NB) for an accurate quotation.
- Application Submission: This phase requires submitting essential documents, including the Quality Management System (QMS) and technical specifications of the device. Class III devices and certain Class IIb devices need additional supporting documentation.
- Application Review and Compliance Verification: After submitting the application, the Notified Body will review the documentation and perform necessary audits and testing to verify regulatory compliance with the MDR.
- Post-certification Surveillance: Once a device is certified, it is subject to ongoing surveillance audits and regular assessments to ensure it continues to meet the requirements of the MDR.
The Role of the Authorized Representative
One of the key elements of the certification process is the role of the Authorized Representative. For non-EU manufacturers, the Authorized Representative acts as the official liaison between the manufacturer and the European authorities. They play a crucial role in ensuring that the device complies with European standards and regulations, facilitating the process of market access and regulatory approval.
How the Team-NB Guide Helps Ensure Compliance
This guide is designed to help manufacturers understand each step of the certification journey, from initial application to maintaining regulatory compliance throughout the product’s lifecycle. It provides detailed information on how to navigate the EU MDR, ensuring that medical devices can be placed on the market safely and efficiently.
The Team-NB Guide is a must-read for all manufacturers involved in the medical device certification process. To download the full guide and learn more about how the MDR certification process works, click below.
Download the Full Team-NB Guide
If you are a manufacturer looking for support with the MDR certification process, Authorized Representative services, or regulatory compliance, don’t hesitate to contact us. Our expert team can guide you through the process and ensure that your device meets all necessary EU regulations.
