Medical Devices – Latest Updates

MDCG 2022-11 revised: Notice to manufacturers to ensure timely compliance with MDR requirements

11 December 2023

MDCG 2022-11 Revision 1, published in November 2023, targets the timely compliance with the MDR requirements by manufacturers and notified bodies while ensuring a fair certification process. Both issues are addressed equally to enable an efficient approach to conformity assessment.

The position paper calls on notified bodies to improve the conformity assessment procedure (primarily its transparency, deadlines, predictability, and consistency) by taking particularly into account the financial capabilities of SMEs. To avoid incomplete applications, notified bodies are required to provide regulatory guidance or technical information throughout the assessment procedure. It is emphasized that as part of the pre-application and conformity assessment, these activities are not a chargeable service. Notified bodies will have to regularly update the information on product certification.

Manufacturers are encouraged to make use of transition periods to complete their application for conformity assessment.  They are also urged to ensure timely submission and regular transmission of product data because the conformity assessment procedure under the MDR is more time consuming as compared to previous regulations. One of the major reasons for longer certification process is incomplete application forms or missing data.

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