EU Update: New MDCG Guidance Document 10a

By Annette van Raamsdonk

Medical device manufacturers selling in the European market will want to take note of the compliance requirements of several new guidance documents.

It has been a busy October month for the European Commission (EC) and for stakeholders participating in the relevant Medical Devices Coordination Groups (MDCG). With the adoption of Regulation (EU) 2024/1860, not only the transitional timelines for IVD manufacturers changed, a new approach on the out role of EUDAMED was announced, but also a new regulatory requirement for both medical device manufacturers as IVD manufacturers was introduced: Article 10a.

What is Article 10a about?

The aim of article 10a is securing the availability of medical devices and IVDs in the EU and avoiding a discontinuation of healthcare. Article 10a requires manufacturers to proactively inform the relevant Competent Authority (CA) and health institutions before the supply of certain medical devices or IVDs is interrupted or discontinued.

You most likely have lots of questions: When to report, what to report, who to inform, as well as when this requirement enters into force. This is why the Q&A on “The information obligation in case of interruption or discontinuation of supply of certain medical devices and In Vitro Diagnostic Medical Devices”  is published.

Article 10a applies as of January 10^th, 2025 (Article 3 Regulation (EU) 2024/1860) and it is a separate reporting obligation then the “regular” vigilance and PMS reporting requirements. The requirement to report the interruption or discontinuation of supply of certain devices lies with the manufacturer (whether located in or outside the EU). The manufacturer must inform all economic operators (EO) and healthcare institutes to whom they directly supplied a device. The informed EOs are responsible for cascading the information provided by the manufacturer to the downstream supply chain.

It is up to the manufacturer to determine whether it is foreseeable that the interruption or discontinuation could lead to serious harm. This sentence caused quite some discussion during the creation of the document since medical practitioners might rely on a certain device due to having trained their personnel in the use of this specific device compared to another alternative. The manufacturer might not always be aware of this. That is why the document gives some examples of possible indicators that need to be considered during the assessment of the manufacturer whether reporting is required. For example, is the device a life-saving device, is the device intended for a vulnerable patient group, the market share of the manufacturer etc. (Q. 9.2).

Reporting should be done at least six months before the manufacturer’s anticipated interruption or discontinuation is expected to occur.

Other questions that are addressed are for example, what is meant with “anticipation of an ‘interruption or discontinuation” (Q.7), what types of categories of reasons there are (Q. 8), how “serious harm or a risk of serious harm to patients or public health” should be understood (Q. 9, aligned with the definition provided in MDCG 2023-3), and more.

What can be expected on 10a?

The Q&A is completed, though the discussion on the form that manufacturers are expected to use when reporting in accordance with article 10a is still ongoing. Also, decision tree diagram, to assist the manufacturer in assessing the risks related to determine whether the interruption or discontinuation in the supply of the device may result in serious harm to patients or public health, is still under development. So, stay tuned, we at Emergo will report the results as soon as these documents are published.