DATABÁZE LÉKŮ
Reporting of Interruption or Discontinuation of Supply of certain medical devices by the Manufacturer (In accordance with art. 10 a)
On 10 January 2025, the provisions of Article 1(1) and Article 2(1) of REGULATION (EU) 2024/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the phasing-in of the Eudamed database, the obligation to notify in the event of interruption or termination of supply and transitional provisions for certain in vitro diagnostic medical devices shall enter into force.
Where a manufacturer anticipates an interruption or a discontinuation of the supply of a device, other than a custom-made device, and where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation.
The information referred to in the second subparagraph shall, other than in exceptional circumstances, be provided at least 6 months before the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority.
For reporting purposes it is recommended to use Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (MIF).
Text: The completed MIF (Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (MIF)):
by data message (mailbox identifier: qwfai2m), by e-mail – to the following e-mail address: clanek10a@sukl.gov.cz or posta@sukl.gov.cz
The reporting format should follow the structure of the MIF form, which must not be missing:
- Type information (Interruption/discontinuation),
- Manufacturer information/authorised representative information,
- Subject device and its specification,
- When is the interruption/discontinuation of supply estimated to start, and when is the interruption/discontinuation estimated to end,
- The countries in which the device was placed on the market
- The countries that are impacted by the interruption/discontinuation
- Availability of alternative means (Do you manufacture a similar alternative product with a similar intended purpose)
- Reason for the Interruption or Discontinuation of Supply
A “discontinuation of supply” should be understood to include when a manufacturer can confirm that it will cease the supply of a device and therefore no longer places the individual devices of this model or type on the Union market.
An “interruption of supply” should be understood as the consequence of a manufacturer confirming that they cannot or are unwilling to operate as previously intended or planned in relation to the supply of a device, which can lead to a temporary disruption of supply. With the view to making the application of the Article 10a information obligation workable in practice and to avoid unnecessary reporting, an interruption of supply should be understood as having a temporary inability to place individual devices of a given model or type on the Union market, with an expected duration of more than 60 days, as a general indication. However, this should not prevent the manufacturer from notifying of a supply interruption lasting less than 60 days if they assess that this may result in serious harm or a risk of serious harm to patients or public health.
The information should, other than in exceptional circumstances, be provided to the relevant actors referred to in Article 10a (1) of the MDR/IVDR at least six months before the manufacturer’s anticipated interruption or discontinuation is expected to occur.
Interruptions of supply shall be reported without delay.