Aug 12, 2022

The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance covering designation, re-assessment and notification of Notified Bodies (NBs) as well as conformity assessment bodies under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

Setting expectations for NB designation timeframes

The new guidance does not directly address or solve issues related to NB capacity concerns as medical device and IVD manufacturers seek certification or recertification to MDR and IVDR requirements; however, the guidance should help manage expectations related to the time needed for NBs and conformity assessment bodies to obtain MDR and/or IVDR designation. The MDCG guidance aims to provide an overview of the assessment steps necessary for designation and re-designation, as well as associated timelines. In addition, the guidance essentially gives a high-level overview of information already available in the MDR and IVDR, as well as in other currently available MDCG guidances covering NBs.

Two flowcharts are included that illustrate the process and estimated timeframes of NB designation processes, which the guidance projects to be a minimum of 20 months.

The new guidance does not go into detail regarding which documents will need to be provided for review under designation-related processes.

Re-assessment requirements and NB capacity questions

Article 44 (10) of the MDR and Article 40 (10) of the IVDR both state that “three years after notification of a notified body, and again every fourth year thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII of the MDR and IVDR shall be conducted by the designating authorities and a joint assessment team.”

The re-assessment process takes a significant amount of time for NBs as well as designating authorities. An NB undergoing re-assessment will have less capacity to perform assessments for medical device and/or IVD CE Mark certification audits. The MDCG does not address this challenge in the new guidance.

(As of August 12, 2022, there are 32 NBS designated under the MDR and seven NBs designated under the IVDR.)

However, the European Commission continues to work on an action plan to address NB capacity shortage challenges. Authorities in The Netherlands have taken the lead in developing a draft action plan, to which Emergo by UL has contributed input.

Emergo by UL consultants in Europe will provide further updates and analysis once the draft action plan has been published.

Annette van Raamsdonk is Senior Regulatory Affairs Consultant at Emergo by UL.

Learn more about medical device and IVD regulations in the European Union:

Author

  • Annette van Raamsdonk

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