The latest update to the medical device regulations aims to protect patients from supply interruptions, but this may eventually result in more red tape for companies.
Medical technology companies take their responsibilities to patients and health systems very seriously. Their daily focus is to deliver devices and solutions that are safe and performing, so that patients and their health professionals can achieve the best possible outcomes.
Part of this responsibility is planning and managing the manufacture and availability of millions of products every year. If supply is disrupted for any reason – due to a lack of raw materials, staff shortages and natural disasters – companies do everything in their power to find a solution. It is in everyone’s interest that surgical gloves, cardiac implants, blood tests and medical lab equipment to name just a few get to where they are needed.
Now, a new addition to the EU medical device regulations aims to minimise the impact of these kinds of disruptions. However, I’m concerned that it does little to protect patients and health systems but adds to the workload of companies and at the end have the opposite effect.
Let’s look at the new rule. But first, a quick refresher on how EU regulations affect market access.
Before new medical devices and diagnostic tests reach patients or healthcare professionals, they must be CE-marked. This process is governed by EU rules: The Medical Devices Regulation (MDR) and the In Vitro Diagnostics Medical Devices Regulation (IVDR). Both were published in 2017 and came into force in 2021 and 2022, respectively, at the end of transition periods.
Last summer, the Commission published Amending Regulation 2024/1860, which, among other things, included Article 10a. That article states that manufacturers must notify the EU authorities and their customers of supply interruptions and device discontinuations in advance if this could pose a risk of severe harm to patients. Here, perhaps for the first time, we have an article that addresses the lack of medical devices rather than regulating market access (which is the core purpose of the MDR/IVDR).
So, what does it mean for manufacturers?
Companies will need to continuously monitor for potential supply disruptions, such as missing components, production problems, certification issues and so on. In instances where the manufacturer cannot supply a product, it should watch out whether other companies may be able to supply an alternative. If there is a supply issue which is not addressed by a competitor, and if this might put patients at risk, companies must inform their home authorities.
According to the new requirement, the manufacturer should inform authorities and their direct customer at least six months before the problem occurs with a standardised, electronically submittable notification form.
The change applies from 10 January 2025. In December, the European Commission published explanatory information about its implications. MedTech Europe and Hogan Lovells Brussels hosted a webinar on 18 December in an effort to brief medical technology companies on their new responsibilities. It seems likely that many, in particular small and medium enterprises (SMEs), will not be aware of the new requirement.
At the time of writing, we await the publication by the Commission of a decision tree to help with this process. Curiously, while the obligations on manufacturers are set out in Article 10a, there is no mention of what authorities should do with notifications of supply problems received from companies (being obliged or authorized to take certain action).
To me, it appears the new requirements will add to companies’ administrative burden, without supporting them to comply nor stating how it will actually help patients.
Crucially, the implications of Article 10a, insofar as they can be interpreted at this point, mean manufacturers will need to develop a full-blown process and implement it in their quality management. Otherwise, they risk being non-compliant and may lose therefore their QMS certification. And while some countries are yet to specify the consequences of non-compliance, others seem to have existing provisions in their national laws which may apply and set out heavy penalties ranging from fines to imprisonment.
These are points stakeholders might have made if a discussion had taken place well in advance of these responsibilities coming into force. In the meantime, MedTech Europe is working to raise awareness among the sector while engaging with the Commission and authorities to highlight the practical challenges this change implies.
