MDCG Guidance: Streamlining Notified Body Processes Under EU MDR and IVDR

The Medical Device Coordination Group (MDCG) has issued four new guidance documents to streamline the processes for Notified Bodies under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). These documents are designed to enhance the clarity and efficiency of assessments conducted by Designating Authorities (DAs) and Conformity Assessment Bodies (CABs).

What are the four new guidance documents?

• • MDCG 2024-6: Preliminary Assessment Review (PAR) Form Template (MDR) – This document provides a standardized form for DAs to use when reviewing a Notified Body’s (NB) documentation during reassessment. It is part of the procedures outlined in MDCG 2022-13 and ensures that all necessary aspects of the NB’s documentation are systematically evaluated.

• • MDCG 2024-7: Preliminary Assessment Review (PAR) Form Template (IVDR) – Similar to MDCG 2024-6, this form template is specific to the IVDR. It is used by DAs to review the application of a CAB, ensuring that the review process is thorough and consistent before submitting the final form to the European Commission to initiate the appointment of a Joint Assessment Team.

• • MDCG 2024-8: Preliminary Re-Assessment Review (PRAR) Form Template (MDR) – This template is used for the re-assessment of a CAB under the MDR. It facilitates the DAs’ review process and ensures that all relevant information is captured before the appointment of a Joint Assessment Team, as per Article 35(3) of the MDR.

• • MDCG 2024-9: Preliminary Re-Assessment Review (PRAR) Form Template (IVDR) – This document serves the same purpose as MDCG 2024-8 but is specific to the IVDR. It ensures a structured and comprehensive re-assessment process for CABs, following the guidelines in Article 35(3) of the MDR.

These documents complement MDCG 2022-13, which details the procedures for the designation, re-assessment, and notification of conformity assessment bodies and notified bodies. This overarching guidance provides the framework within which the new templates operate, ensuring that the designation and reassessment processes are efficient and standardized.

Conclusion:

These new guidance documents are crucial for entities involved in the designation and reassessment of Notified Bodies but have limited immediate impact on manufacturers or other stakeholders unless they are seeking designation or reassessment as a Notified Body.

For more detailed information, you can visit the European Commission’s page on MDCG-endorsed documents and other guidance.

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If you need help in understanding the new guidance documents, or have questions about how these updates will affect your medical device or IVD, contact us so our consultants can assist you.

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