Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices

MDCG 2024-16 V 1.02

MDCG 2024 – 16 Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746) This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the Eu ropean Commissi on. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.

1 Administrative information

Name of National Competent Authority (NCA) to which this report is sent Type of information o Initial information o Additional information (voluntary)* o Follow-up information (voluntary)* *Please specify modified sections of the form (if additional or follow-up information): Date of information Reference number assigned by the manufacturer (if any) Reference number assigned by NCA (as applicable)

2 Information on submitter of the report

Status of submitter o Manufacturer o Authorised Representative (if mandated to act on behalf of the manufacturer) o Other entity (if acting on behalf of the manufacturer)

3 Manufacturer Information

Manufacturer organisation name Single registration number (if filled here and already EUDAMED registered, please leave following fields in this section 3 open) Address Postcode City Phone Fax E-mail Country

4 Authorized Representative Information (if applicable)

Authorised representative organisation name (if mandated to make this report on behalf of the manufacturer) Single registration number (if filled here and already EUDAMED registered, please leave following fields in this section 4 open) Address Postcode City Phone Fax E-mail Country

5 Other entity (if applicable)

Organisation (if completing this report on behalf of the manufacturer) Address Postcode City Phone Fax E-mail Country

6 Medical device information

Risk class of device

MDD/AIMDD IVDD

IVD Annex II List A IV D Annex II List B AIMD Active implant MDD Class III MDD Class IIb MDD Class IIa IVD for self-testing MDD Class I IVD general MDD Class I sterile MDD Class I measuring function

MDR IVDR

Class III Class D Class IIb Class C Class IIa Class I Class I sterile Class I measuring function Class I reusable surgical instruments Class B Class A Class A sterile Device Identification Please fill this section when reporting on an individual device. Where reporting on several devices, complete the ‘MDCG 2024-16 Annex - Device Identification Table’. Reports on several devices should be for the same manufacturer, the same interruption or discontinuation and same associated reason (See ‘reasons’ in section 7). Unique Device Identification (UDI-DI)/EUDAMED ID (if applicable) Basic UDI-DI/Eudamed-DI (if applicable) If the above UDI section is completed and the device is already registered in EUDAMED, please leave the following fields blank and go to ‘Intended use’ field. If filling out the following fields for devices without UDI-DI/ EUDAMED DI, please complete all mandatory fields. Model Catalogue/reference number Nomenclature system (e.g. EMDN) Nomenclature code Nomenclature text Commercial name/ brand name / proprietary or common name Intended use according to the IFU or add IFU in attachment (voluntary)

7 Description of the Interruption or discontinuation of supply (information requested as per Art 10a) Specify if the report concerns an interruption or discontinuation o Interruption o Discontinuation Reason for the Interruption or Discontinuation of Supply please select: Regulatory issue Supply chain issue Manufacturing issue Other Additional information on reason for the interruption or discontinuation of supply (voluntary) Information on the assessment of the situation (If available) Device used in a serious, acute or chronic pathology, life-sustaining or life-saving device or accessory Intended for a specific population (e.g., vulnerable populations such as paediatric or geriatric patients) Disruption or interruption limiting / preventing the patients from accessing treatment Device without or with limited available alternatives, or consumable device not replaceable by any other type/brand Major market share in one or several members states Other Additional information on the assessment of the situation (if available) Duration When is the interruption/discontinuation of supply estimated to start? When is the interruption estimated to end (if available)?

The medical device is usually marketed and supplied to the following countries: (voluntary) The countries that are impacted by the interruption/discontinuation: Information Notification(s) regarding the interruption or discontinuation of supply have been sent: Notification to HI/HCPS Yes No Not Applicable Date Sent (DD/MM/YY) Notification to AR Yes No Not Applicable Date Sent (DD/MM/YY) Notification to importers Yes No Not Applicable Date Sent (DD/MM/YY) Notification to distributors Yes No Not Applicable Date Sent (DD/MM/YY) Attached files (Voluntary) 8 Additional information on Interruption or Discontinuation of Supply (voluntary) This section allows manufacturer, on voluntary basis or on the request of a competent authority, to share additional information Possible mitigations measures: to reduce the impact of the interruption or discontinuation of supply. Is the redistribution of EU or Global stocks an option? Yes No Do you manufacture a similar alternative product with a similar intended purpose ? Yes No Details of the remaining inventory / existing stock level at EU level If applicable, please provide information in attached file Progress update on the interruption or discontinuation of supply