Vagueness of Article 10a is cause for concern

ROTTERDAM, NETHERLANDS – A recent regulation requiring medical device and in vitro diagnostics manufacturers to report discontinuations or disruptions of their products at least six months in advance of a product shortage is overly vague and challenging for manufacturers, a panel of experts said at RAPS 2025 European Lifecycle Management conference. Despite the challenges, they advised manufacturers to consider the requirements as part of their post-market requirements and ensure they have a process in place to notify stakeholders about product shortages.

Under Article 10a of EU Regulation 2024/1860, some medtech manufacturers are required to notify competent authorities, health institutions, or economic operators that their products may face shortages. Liz Gommans, a regulatory affairs and technical specialist with DEKRA B.V., Netherlands, noted that as a notified body, her organization has limited involvement with Article 10a requirements. However, she stated that during quality management system (QMS) audits, they ask questions related to product shortage notification requirements, such as whether the company has assigned personnel to specific roles and whether it has a means of determining which products are considered critical under Article 10a. She emphasized that companies should document their risk assessment and explain why they determined a product to be critical or not.

“Basically, we only check actually if all the requirements are in there, and if you have a system to communicate with your economic operators who can then downstream, make sure that it eventually ends up with the hospitals,” said Gommans. “In some cases, where the manufacturer directly delivers to hospitals… We also check if the downstream process is there.

“We are also not notified by the competent authorities if something is happening, only if it has an effect on the certificate, really,” she added. “We check the requirements, basically as a notified body.”

Erik Vollebregt, an attorney with Axon Lawyers, echoed the statement and said that notified bodies need to be told of product discontinuations and interruptions if they affect their conformity assessment and quality system requirements.

According to the panel, one of the problems with Article 10a is its vague terminology and lack of clarification on what constitutes a critical device that requires notification. Vollebregt said that it signifies how badly the legislation was written.

“We see these companies here [straining] to get a hold on all these if-and-but words like ‘reasonably anticipate,’” said Vollebregt. “You need to evaluate this on a case-by-case basis, per device. That is undoable for [some companies], because there's just too much going on.”

The vague language has also been inserted into the form developed by member states, which is used to notify stakeholders about potential product shortages. It doesn’t match the European Commission’s guidance on the issue, he noted.

“That really shows that everybody is making this up as we go,” said Vollebregt. “Basically, that is what, from a legal perspective, is deeply problematic for somebody who likes well-organized rules.”

Gommans said that manufacturers often ask if their products would be considered critical, but as notified bodies, she stated that they are not in a position to answer that question; instead, the manufacturers themselves should make that determination. She said that bigger manufacturers are better equipped to implement Article 10a requirements compared to small and medium-sized enterprises (SMEs).

“With SMEs, most are aware, but they're very uncertain about how to implement it,” said Gommans.

She also noted that SME supply chains tend to be less well-structured, and they don’t always know six months in advance if there will be a disruption to the supply chain.

Vollebregt noted that Europe does not have a planned economy for medical devices, and manufacturers have the right to discontinue products.

“You are perfectly allowed as a manufacturer to say, ‘Look, we are taking this product off the market because it's not profitable for us,” he said.

However, on the national level, Vollebregt said that hospital systems may include clauses in their tender agreements that require manufacturers to supply a similar product in the event of a supply shortage, which may be problematic if a company is trying to fulfill its Article 10a obligations. If a company issues a notice that a product may be in short supply in six months under Article 10a, regardless of whether that happens, he says that it may lead the hospital system to give its contract to another product supplier.

Vollebregt advised that manufacturers should consider Article 10a notification requirements as part of their overall post-market surveillance (PMS) plan. He said that competent authorities may not accept the requirements as just part of a product’s QMS and should not be treated as a standalone notification requirement. Furthermore, he said companies should anticipate freedom of information requests from competitors who may use Article 10a as an excuse to get sensitive information through competent authorities.

“I work for several manufacturers that really have had some very interesting and damaging information of theirs go out into the public, because a freedom of information request was granted, and the information is public to everybody,” said Vollebregt. “Literally, your business secrets are out on the street, and you may want to make sure that within your company, you have the process for following up on these information requests when they happen, so the authority that implements those will check with you.”

Vagueness of Article 10a is cause for concern

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