Regulation 2024/1860 – an overview

On 9 July 2024, Regulation (EU) 2024/1860 was published, which introduces significant amendments to Regulations (EU) 2017/745 MDR and (EU) 2017/746 IVDR. The amendments focus on three key areas:

  1. The gradual introduction of EUDAMED
  2. The obligation of manufacturers and economic operators to inform in case of interruption or discontinuation of product availability, and
  3. Transitional provisions for certain in-vitro diagnostics

The following article will focus on the new reporting obligation for manufacturers in the event of supply interruption or discontinuation. We will discuss the key requirements and specific aspects that need to be taken into account during implementation. The new Article 10a(e) is not yet visible in the MDR/IVDR but will enter into force on 10 January 2025.

Article 10a – Obligation to report interruption of discontinuation of supply

The central part of Regulation (EU) 2024/1860 lies in the future Article 10a(e) of the MDR / IVDR, which describes the responsibilities of manufacturers in the event of interruption or discontinuation of the supply of certain medical devices.

If a manufacturer plans to interrupt or discontinue the supply of a medical device that is not a custom-made product and there is a risk of significant harm to patients or public health, notification is mandatory.

The manufacturer must inform the competent authority of the Member State in which he or his authorised representative is located. Affected economic operators, healthcare institutions and healthcare professionals who purchase the product directly must also be informed of the planned measure in good time. This obligation serves to prevent potential supply interruption or discontinuation or risks to public health at an early stage.

Apart from exceptional cases, the above information must be provided at least 6 months before the planned interruption of supply. The manufacturer must inform the competent authority of the reasons for the interruption or discontinuation in the information provided.

 

To which medical devices does the regulation apply?

The requirements of the article are relevant for all models and types of products placed on the market in the EU. In detail, this means

  • assessment by the manufacturer: The manufacturer is obliged to assess whether an interruption or discontinuation of supply of its product is likely to cause serious harm or a significant risk to the patient or public health. This assessment must be made on a realistic and comprehensible basis.

it also applies to legacy devices: The regulation also explicitly covers so-called legacy devices in accordance with Article 120 (3a) and (3b) of the MDR and Article 110 (3a) and (3b) of the IVDR

Responsibilities, processes and requirements: what manufacturers need to consider now

What exactly is regulated?

From 10 January 2025, the new requirements for reporting supply interruptions and discontinuations will come into force and must be implemented. The European Commission has prepared a Q&A guidance document to clarify the first urgent open questions. The following rules apply:

  • Notifications before the deadline: Supply interruptions or discontinuations that the manufacturer expects before 10 January 2025 do not have to be reported – even if the interruption does not occur until after this date.
  • Information for users: Manufacturers are nevertheless required to inform users of their products about imminent supply interruptions or failures.
  • Responsibility of the manufacturer: The responsibility to fulfil this information obligation remains with the manufacturer and cannot be delegated. However, support by authorised representatives, economic operators or third parties is permitted in order to implement the operational tasks in this context.
  • Downstream information flow: All economic operators are obliged to pass on the information provided by the manufacturer unchanged along the supply chain to the users.

These regulations are aimed at improving transparency in the supply chain and recognising potential supply interruption or discontinuations at an early stage.

 

Who receives notifications?

The manufacturer must inform the following authorities:

  • Economic operators, health institutions and healthcare professionals to whom the product is supplied directly
  • The competent authority of the Member State in which the manufacturer or his authorised representative is established

Since December 6, a “Manufacturer Information Form” for reporting to the competent authority is available, which specifies the information required for submission: MDCG 2024-16 Form on Interruption of Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices

 

When do you report?

The timing of the notification plays a decisive role. Manufacturers are obliged to notify potential supply interruptions or discontinuations, in particular planned interruptions, at least 6 months in advance. However, where possible, the notified bodies recommend earlier notification to allow sufficient time for countermeasures.

In the event of exceptional circumstances, such as unexpected supply interruption or discontinuation of raw materials, natural disasters or sudden economic challenges, a short-term notification may be accepted. However, this must be done immediately in order to minimise the impact on supply.

 

What is important in terms of content?

In addition, manufacturers must be familiar with the relevant terminology in order to be able to determine the right time for necessary measures and notifications. This includes the following:

  • “Anticipation”: This refers to confirmation/information by the manufacturer of an impending interruption or discontinuation of product shipments. It includes:
    • analysing the problem/business decision at hand
    • the evaluation of risk mitigation measures
    • the development of suitable communication strategies for the affected interest groups

The concept of “anticipation” refers to the company’s own products and not to the products of other manufacturers, but takes into account their market share and potential impact on the supply situation.

  • “Interruption of supply”: The manufacturer informs that he will be unable to supply a product as intended or planned for approximately 60 days. However, if the manufacturer considers it possible that an interruption of less than 60 days may also lead to serious harm or a risk of serious harm to patients or public health, he is equally obliged to report it.
  • “Discontinuation of supply”: The manufacturer informs that a product, product model or type of product is no longer distributed and thus no longer placed on the Union market.

It is crucial to clearly define what is considered as an “interruption or discontinuation that may result in serious harm or risk of serious harm to patients or public health”. An example of this is when a particular diagnostic method or patient therapy is not available in one or more Member States, which may result in serious harm or risk of serious harm to patients or public health.

Cases in which “unavailability” may lead to “serious harm or the risk of such harm” include cases in which patients are threatened with

  • an immediate risk of death
  • a serious deterioration in the state of health or
  • a life-threatening condition

and for which no suitable alternative diagnostic method or therapy is available.

Obligations of other economic operators

Not only manufacturers must be active and disseminate the information on supply interruption or discontinuations to the intended recipients. Economic operators who have received the information referred to in paragraph 1 of Article 10a, either directly from the manufacturer or from another actor in the supply chain, are obliged to immediately inform all other economic operators, health institutions and healthcare professionals to whom they directly supply the device of the planned interruption or discontinuation of supply.

This ensures that information about a supply disruption is passed on along the entire supply chain and that individual economic operators pass the information on to all downstream economic operators in the supply chain. This must be done “without undue delay”, which means that the information must be passed on as quickly as possible, without intentional or negligent delays. The aim is therefore to pass on information quickly so that downstream actors can react in good time and take measures to minimise the damage.

In addition, Article 25 MDR/IVDR obliges economic operators to ensure traceability along the supply chain. They must be able to identify their direct suppliers as well as the actors and organisations to which they have supplied products.

Preparations you can make as a manufacturer

The question now arises as to what manufacturers can do specifically in preparation for the implementation of Article 10a.

In order to fulfil the reporting obligation correctly, it is important to define internally how the assessment of a possible report is determined. In addition, it is also the manufacturer’s responsibility to evaluate whether the interruption or discontinuation of the supply of the product concerned could lead to serious harm to patients or public health. The following criteria can be applied for this purpose:

  • The potential for serious harm to patients in the population as a whole should be determined and considered. An assessment based on an individual patient should be avoided.
  • Assessment based on information limited to the manufacturer’s knowledge of its own product range.
  • The manufacturer may seek information from other healthcare professionals to assess the impact of an interruption of care on the safety and health of the patient.

The following factors may be used to determine whether a likely supply disruption or discontinuation may result in serious harm to patients or public health:

  • The importance of the device for ensuring essential healthcare services (Is the intended purpose of the device for life-sustaining measures?)
  • Alternative solutions (Can suitable successor products or other alternatives be made available?)
  • Other factors, such as objective reasons, whether the interruption or discontinuation of supply of a particular product or product range is to be expected; the quantity of products and stocks already available, deadlines for the procurement of alternatives for these products, remedial measures to prevent the interruption

In any case, the manufacturer must implement an internal process in his QMS, taking into account the criteria mentioned, so that the necessary assessment of possible supply interruption or discontinuation can be correctly evaluated and further steps can then be implemented. This procedure should follow the risk-based approach.

The processes affected would therefore be in all likelihood:

If you need support with the implementation of the new Article 10a on the obligation to report supply interruption or discontinuation, please do not hesitate to contact us – we will be happy to assist you without delay and will work with you to implement a streamlined solution that is right for you. Various services can be offered here, such as workshops for knowledge building and also process adaptation with regard to supplier management, reporting systems and risk management in conjunction with the corresponding risk assessments

Please note that all details and listings are not intended to be exhaustive, are without guarantee and are for information purposes only.