Feature - What You Need to Know about Article 10a

What Should Device Manufacturers Know and Do About Article 10a to Prevent Device Shortages?

By Lawrence Yeh

To mitigate risks to public health because of medical device shortages, the MDR and IVDR will require additional requirements in a soon-to-be infamous “Article 10a.” Here is what you need to know about it, and what you need to have done yesterday, to comply with the amended regulations. 

[Download the Complete Guide to Article 10a Compliance and Mastery]

What is the scope of Article 10a? 

Article 10a applies to all devices under the MDR / IVDR, except custom-made devices, which have been placed on the Union market; this includes legacy devices. There are 2 scenarios in which manufacturers need to assess the need to inform certain stakeholders: 

1. There is a temporary inability or unwillingness on the manufacturer’s part to place a device on the market (60+ days as a guideline but not a strict rule) AND this supply interruption could result in serious harm to patients or public health,

   or

2. The manufacturer will permanently stop placing a device on the market, AND this discontinuation could result in serious harm to patients or public health.

The overall picture 

At a high level, Article 10a essentially creates a communication chain, where each stakeholder must inform the next stakeholder of anticipated (that is, reasonably foreseeable) product interruptions or discontinuations. 

Not all interruptions or discontinuations – specifically those that could result in serious harm (or even just risk of serious harm) to patients or public health. 

The manufacturer of devices placed on the union market informs the competent authority of their Member State where the manufacturer is located. There is a form for this, MDCG 2024-16. If the manufacturer is outside the EU, then it is the competent authority where the authorised representative is located. The competent authority then informs other impacted competent authorities and the European Commission.  

Depending on how the manufacturer places the devices on the market, the manufacturer directly informs the health institutions and healthcare professionals to whom they supply devices, or the manufacturer informs the importers and distributors, who then pass on the message to the downstream health institutions and healthcare professionals.

Why this is happening

In essence, it is a mechanism allowing the member states to identify product shortages.

That was the intention of the lawmakers, knowing that they have regulatory bottlenecks, to somehow become aware of device shortages early enough to be able to react. They don’t need to know all product shortages, only some, so let’s talk about the scope and other details on LinkedIn for more insights on all things related to medical devices! 

Identifying a supply interruption or discontinuation 

At least 6 months prior to an anticipated supply interruption or discontinuation, manufacturers are required to submit the MDCG 2024-16 form. The manufacturer needs to consider situations including — but not limited to — a regulatory, supply chain, or manufacturing issue. In more tangible terms, this would include situations such as not having a valid certificate, deciding not to pursue certification anymore, the emergence of device performance issues, encountering difficulties in obtaining components necessary for manufacturing, or financially driven decisions to suspend or discontinue product lines. 

The manufacturer also needs to identify reasons why this may present a risk of serious harm, such as the device being a life-sustaining or life-saving device or accessory, or a device intended for a vulnerable population, such as paediatric or geriatric patients, and whether or not the lack of the device on the market would prevent patients from accessing treatment. 

There are allowances in the amended regulation for exceptional circumstances, which are unforeseen situations where the manufacturer is unable to anticipate or confirm a supply interruption or discontinuation. 

Example scenarios include a natural disaster, a sudden inability to obtain raw materials or components, or economic or financial circumstances. In these cases, the manufacturer must simply inform the stakeholders without undue delay. 

I’m overwhelmed, what do I do now?