Pursuant to the Q&A document published by the EU Commission, the manufacturer (or any relevant actor on behalf of the manufacturer) will need to inform the competent authority of a interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices using a form referred to as the ‘Manufacturer Information Form.’
As outlined in Question 12 of the Q&A document, manufacturers are required to include all mandatory information (i.e., information not marked as voluntary) in the ‘Manufacturer Information Form’ when submitting a notification to the competent authority of the Member State where the manufacturer or its authorised representative is based. Manufacturers may also voluntarily provide the competent authority with updates or relevant changes to the submitted form by submitting a revised version, indicating either ‘additional information’ or ‘follow-up information’ in Section 1, under ‘type of information’ in the MIF. When submitting an updated form, the manufacturer should specify which sections have been amended (e.g., Section 2, sub-section ‘X’). In sections marked as “voluntary,” manufacturers can include extra details regarding the interruption or discontinuation, which may assist the competent authority in assessing the situation.
The Manufacturer Information Form referenced in the Q&A document can be accessed using the following link
The Device Identification Table can be accessed using the following link
