A Comprehensive Guide to the MDR Certification Process with Notified Bodies
Getting medical devices certified under the Medical Devices Regulation (MDR 2017/745) can be a challenging and time-consuming process. Notified Bodies (NBs) are essential in this journey, ensuring that your devices comply with the EU's strict safety and performance standards. In this blog, we’ll simplify the MDR certification process based on Team NB's consensus document, offering a step-by-step guide and useful tips to help manufacturers navigate the process more efficiently.
Purpose and Scope of the MDR Notified Body Certification Process
The certification process applies to both:
Legacy Devices: Devices transitioning from the Medical Device Directive (MDD) to MDR under Article 120.
New Devices: Those introduced post-MDR implementation.
The process covers all key stages, from pre-application to post-certification, but does not include recertification or specific cases like Article 16 and Article 117 procedures.
Key Phases of the Notified Body Certification Process
The certification journey comprises three main phases, they are:
1. Pre-Application Phase
Initial Contact and Submission: The manufacturer initiates contact with the NB to request conformity assessment services, providing pre-application information as per Annex VII §4.2 (d) of MDR.
Pre-Application Review and Quotation: The NB evaluates the information to confirm the product falls under MDR, verifying its classification. Based on this, the NB provides a cost estimate for the conformity assessment.
2. Application Phase
Formal Application Lodging: The manufacturer submits technical and quality documentation, including:
Quality Management System (QMS) evidence per Annex IX §2.1 or Annex XI Part A §6.1.
Technical documentation for higher-risk devices (Class III, IIb with product annex certificates).
Contract and Application Review: After contract signing, the NB evaluates the application’s completeness, classification accuracy, and the NB’s capacity to assess the device.
Conformity Assessment Activities:
QMS Audits: On-site audits to verify compliance with MDR.
Technical Documentation Review: Systematic reviews for Class III devices and sampling for lower-risk classes, adhering to MDCG 2019-13.
Testing and Specific Procedures: Including clinical evaluation consultations and assessments for devices with medicinal substances, human or animal derivatives.
3. Post-Application and Surveillance Phase
Final Review and Certification:
The NB conducts a comprehensive review of all assessments and decides on issuing or refusing the certification.
Certificate Issuance: Certificates are generated in compliance with Annex XII and uploaded to EUDAMED.
Ongoing Surveillance:
Annual QMS audits.
Vigilance monitoring and PSUR evaluations (Article 86).
Unannounced audits at least once every five years.
Critical Success Factors for Manufacturers
Comprehensive Documentation: Ensure pre-application submissions are complete and accurate to avoid delays during the review process.
Understanding Conformity Routes: Familiarize yourself with applicable conformity assessment procedures for your device class.
Proactive Communication: Maintain open lines of communication with the NB, promptly addressing requests for additional information or clarifications.
Vigilance and PMS Compliance: Implement robust post-market surveillance systems to monitor device performance and maintain compliance.
How AF Pharma Supports MDR Notified Body Certification
At AF Pharma, we offer end-to-end support for MDR certification, simplifying the process for manufacturers. Our services include but are not limited to:
Pre-Application Assistance: Helping compile and review the required documentation.
Application Management: Guiding you through technical documentation, QMS preparation, and conformity assessments.
Post-Market Surveillance: Establishing PMS systems and preparing PSURs to meet surveillance requirements.
With deep expertise in EU regulations, we act as your trusted partner, ensuring a seamless certification journey.
Conclusion
The MDR Notified Body certification process is challenging but vital for ensuring that medical devices are safe and effective for the EU market. By mastering each step and partnering with a reliable expert like AF Pharma, manufacturers can tackle the process with confidence and efficiency.
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