New MDCG 2024-16 form released
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New MDCG 2024-16 form released
Thursday, 12 December 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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New MDCG 2024-16 form released
2:12
On December 6th, 2024, the Medical Device Coordination Group (MDCG) released a Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (MDCG 2024-16).
This form shall be used by manufacturers, its mandated authorised representative or any other actor acting on behalf of the manufacturer, to inform Competent Authorities in the case of an interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices as described in Article 10a of the MDR/IVDR.
Some key takeaways from MDCG 2024-16
To inform the relevant competent authority of an interruption of supply, the manufacturer, its mandated authorised representative, or any other actor acting on behalf of the manufacturer should provide the information specified as required in the ‘Manufacturer Information Form’.
The information should then be submitted to the competent authority of the Member State where the manufacturer or its authorised representative is established. It should be noted that Member States may provide additional information on how to submit the information in the form, on the websites of the relevant competent authority.
MDCG 2024-16 provides two new forms. One form includes the actual manufacturer information form which can be used if the reporting consists of one or multiple devices from the same manufacturer. An additional annex is provided which includes the device identification table where multiple devices can be listed.
What does it mean to you?
This guidance introduces a standardized approach to reporting supply issues, which is crucial for maintaining compliance with MDR/IVDR regulations. Proper use of these forms can help you mitigate potential regulatory risks and maintain transparency with Competent Authorities.
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