Overview: EU Parliament’s Vote to Revise the Medical Device Regulations
24 October 2024
October “In All Other News”: MDCG Working Group Updates, New Public Consultations, and more
1 November 2024The EU Commission published a new Q&A on Manufacturers’ Obligation to Inform in Case of Interruption or Discontinuation of Certain Medical Devices. It is available: HERE
Overview of Requirement
Regulation (EU) 2024/1860 introduces a new requirement for Medical Device & IVD manufacturers, added to the MDR/IVDR as Article 10(a).
Additionally, Competent Authorities and Economic Operators further in the supply chain have obligations, if informed by a manufacturer of anticipated interruption or discontinuation.
Key points of the new requirement include:
- It impacts all devices, except custom-made devices, i.e., even legacy devices.
- Manufacturer notification is required when:
- it is reasonably foreseeable, and
- that interruption or discontinuation could result in “harm or a risk of serious harm to patients or public health in one or more Member States”.
- Manufacturers shall:
- other than in exceptional circumstances, provide this notice at least six (6) months in advance, and
- specify the reason for the interruption or discontinuation.
- The notice needs to be informed to:
- the Competent Authority where they, or their Authorized Representative, is located, and
- all Economic Operators (including procedure pack producers), health institutions, and healthcare professionals to whom it directly supplies the device.
- The Competent Authority, upon notification, must inform the other Competent Authorities and the Commission.
- Economic Operators, upon notification, must inform any other Economic Operators, health institutions, and healthcare professionals to whom they directly supply the device.
Impact of New Requirement
It is effective starting Friday 10 January 2025. As a result, manufacturers must ensure they have processes to:
- Identify an anticipated interruption to supply,
- Assess the impact of an interruption to supply or discontinuation of a device, and
- Understand who, and how, to notify when required.
Further, all economic operators in the supply chain should ensure they have a system to implement their downward-stream notifications, from that point onward.
This requirement highlights the obligation for appropriate levels of traceability of devices – Economic Operators should be able to readily identify any other Economic Operator (e.g., distributor, system/procedure pack producer), health institution or healthcare professional to whom they have directly supplied the device.
Overview of Q&A Document
The Commission has provided guidance on the following topics.
What constitutes a temporary interruption of the supply of a device?
The Q&A guide states that this should, in general, be an expected interruption lasting more than 60 days.
However, please note that “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.”
What is “anticipation” of the interruption or discontinuation?
It is specific to the manufacturer reporting and their market share. Specifically:
- Confirmation of its own supply, based on its manufacturing activities or, information received from third parties e.g. critical suppliers,
- Confirmation of its own capabilities to produce the device or
- Its own decision to stop placing the device on the Union market.
The manufacturer is not required to assess or advise regarding:
- Alternate devices which may be an appropriate substitute,
- Available stock in the market in general, or
- Which other manufacturers may be able to produce increased quantities of devices with similar intended purposes.
What constitutes “serious harm or a risk of serious harm”?
This is any serious injury to patients, threat to public health, or where there is a significant probability of this occurring. E.g., shortages of the device may result in a patient’s:
- Imminent risk of death,
- Serious deterioration of their health, or
- A life-threatening condition.
And for which there is no suitable alternative diagnosis method or therapy available.
It can also be due to a healthcare professional’s inability to deliver a specific type of medical treatment.
How to assess if a disruption could result in “serious harm or a risk of serious harm”?
Manufacturers should approach the assessment with the following parameters:
- Not to measure based on a single patient-case scenario, but instead all patients for which the device is intended.
- Assess based on the information at its disposal, i.e., they are not expected to conduct a comprehensive market analysis in order to support its decision.
- Consider consulting with physicians, medical societies, or healthcare facilities to gather impact information.
And consider the following (non-exhaustive) indicators, as appropriate:
- The intended purpose of the device, e.g., is it life-sustaining or life-saving?
- Patient population, e.g., does it impact vulnerable populations, such as pediatric or geriatric?
- If the disruption will limit patients from access to receiving treatment, e.g., are there alternate treatment options?
- Market dependency on the device, and market share of the device
- Level of stockpile available
Please see the Q&A for further (still non-exhaustive) examples.
Note that a decision tree flow chart is recommended, to help with the analysis. If the Commission develops one, they will update the Q&A to add it.
Who specifically does the manufacturer need to inform?
The Economic Operators, health institutions, and healthcare professionals to whom they directly supply the device. And their (or their Authorized Representative’s) Competent Authority.
Once the manufacturer has made their notification, it is then the responsibility of the notified economic operators to further cascade this requirement into the supply chain, until it reaches the impacted health institutions and/or healthcare professionals.
Note the Q&A document provides examples to demonstrate “real life” scenarios (pages 6 and 10).
How does the manufacturer inform the Competent Authority?
The Competent Authority should be notified via a Manufacturer Information Form (MIF). However, release of the form is still pending. Once published, the Q&A will be updated accordingly.
The Manufacturer Information Form will identify the mandatory and voluntary sections to complete.
The manufacturer should identify the reason for the disruption in the form. For example, loss of compliance with MDR Art. 120 / IVDR Art. 110 transition provisions; suspended certificate; voluntary withdrawal from the market; device performance issues; supply chain shortages; etc.
Post-submission, manufacturers may voluntarily provide updates/supplementary details. This can be completed by updating the form, indicating ‘additional information’ or ‘follow-up information’, reflected as voluntary in the Manufacturer Information Form, Section 1, Sub-section ‘Type of Information’. The submitter should specifically identify which sections have been modified.
Further, the national Competent Authorities may individually provide more information on how to submit the form to them. For example, if it should be submitted on their website, then where and how.
Timing to inform under MDR/IVDR Article 10(a)
Manufacturers must notify, other than in “exceptional circumstances”, within six months of the anticipated disruption.
When they know in advance: while the requirement is a minimum of six months, the Commission encourages manufacturers to notify earlier when possible.
When they do not know in advance: notify without undue delay, i.e., as soon as possible, and without any delay that is intentionally or negligently caused by the manufacturer.
The Q&A document advises that an “exceptional circumstance” is when the manufacturer is unable to anticipate or confirm at least six months in advance. For example, a sudden inability to obtain raw materials/components, or an unexpected financial situation.
Can the manufacturer delegate this responsibility?
No. However, manufacturers can “engage the assistance of its authorised representative, other economic operators or a third party, in the practical implementation of the required operational tasks”.
When is notification not required?
When the manufacturer:
- Intends to replace the device with a successor device that covers a similar intended purpose in its place,
- Has a stockpile that can cover demand during the interruption period, or
- Has received information from heath institutions or healthcare professionals that no serious harm or risk of serious harm to patients or public health would occur from its device discontinuation or supply interruption, e.g., alternate devices are available to sufficiently meet demands.
Other Economic Operators’ Obligations
Relevant Economic Operators informed by the manufacturer, should share this information “without undue delay”. They should inform any other Economic Operators, health institutions, or health professionals to whom they directly supply the device.
‘Without undue delay’ means acting as soon as possible, and without any delay that is intentionally or negligently caused by the Economic Operator. This is to ensure the information is rapidly received by anyone else in the communication chain, who may need to further share the information until it reaches the impacted health institutions and/or health professionals.
Note that Economic Operators should not “change, add to or paraphrase the communication received from the manufacturer” when sharing it with other impacted parties.
