Question 1

Initial contact and pre-application phase

Accepted Answer

The initial step in the certification process is establishing contact with a Notified Body (NB) to request conformity assessment services. Manufacturers or their EU Authorized Representatives must provide essential information about the device, its classification, and the scope of certification. As required under Annex VII of MDR, this includes details about manufacturing sites and the technologies involved. Complete and accurate information minimizes delays and enables the NB to prepare a detailed quotation. During this phase, the NB also verifies that the device falls under MDR requirements and assesses its classification.

Question 2

Pre-application review and quotation process

Accepted Answer

Following the submission of pre-application information, the NB conducts a preliminary review to ensure that the device complies with MDR requirements and is correctly classified. Based on this review, the NB prepares a quotation for the conformity assessment services, which may include audits, technical documentation reviews, or testing. The quotation can be updated later if the application changes or new information arises. For Class III or Class IIb devices requiring additional consultations, external experts may be engaged. A precise quotation is critical for efficient process management.

Question 3

Formal application submission

Accepted Answer

Once the manufacturer accepts the quotation, they must formally submit their application, including documentation specified in Annex IX or XI of MDR, such as the Quality Management System (QMS) documentation. For Class III devices, full technical and clinical documentation is mandatory. For legacy devices transitioning to MDR, manufacturers must provide a transition plan. Formal applications often require signing a contract between the manufacturer and the NB, enabling the next stage of conformity assessment.

Question 4

Conformity assessment activities

Accepted Answer

Upon acceptance of the application, the NB begins conformity assessment activities, including QMS audits, technical documentation evaluations, and, where necessary, laboratory testing. The scope of these activities depends on the device classification. For Class III devices, the NB systematically reviews technical documentation, considering applicable harmonized standards and common specifications. Additional consultations, such as with the European Medicines Agency (EMA) for devices containing medicinal substances, may be required. The NB may request further information or adjustments based on its findings.

Question 5

Final review and certificate issuance

Accepted Answer

After completing the required conformity assessment activities, the NB conducts a final review to decide whether to issue or refuse the certificate. This step ensures all non-conformities identified during assessments have been resolved and that the device meets MDR requirements. If the decision is favorable, the certificate is issued for up to five years and recorded in the EUDAMED system. In case of refusal, the manufacturer receives detailed feedback to address deficiencies and resubmit the application if needed.

Question 6

Post-certification surveillance

Accepted Answer

Following certification, the NB carries out surveillance activities, including annual QMS audits, reviews of Periodic Safety Update Reports (PSURs), and sampling-based technical documentation assessments. Manufacturers must notify the NB of any significant changes to their QMS or medical devices. Unannounced audits are conducted at least once every five years. Vigilance data, including incident reports, is reviewed, and corrective actions are implemented as necessary. Post-certification surveillance ensures ongoing compliance with MDR and maintains high safety and quality of standards.

Question 7

<h2><span style="font-weight: 400;">Conclusion</span></h2>

Accepted Answer

The Team-NB consensus document offers a comprehensive overview of the MDR certification process for medical devices. Its structured approach and clear guidelines assist manufacturers in collaborating effectively with Notified Bodies, minimizing errors and delays. Providing complete and accurate documentation at every stage is critical. By adhering to these principles, manufacturers can successfully bring safe and effective medical devices to market, meeting the highest standards of quality and compliance.

News

MDR Certification Process for Medical Devices: Key Insights from the Team-NB Consensus Document

MDR Regulator at Warsaw Medical Expo

MHRA: FDA’s Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

Artificial Intelligence in Medical Devices Questionnaire published by TEAM-NB

MDR Regulator at MEDICA 2024

New EU guidelines for medical device supply continuity – MDR & IVDR

Team-NB’s perspective on MDR and IVDR implementation

Changes in MDCG guidance – borderline products: medical devices & medicinal products

Changes in Code of Conduct for Notified Bodies according to MDR and IVDR – harmonization of activities in the EU