European Commission Q&A details shortage reporting requirements under MDR, IVDR

The European Commission has published a question-and-answer document explaining the responsibilities manufacturers have to alert stakeholders about potential shortages under amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostics (IVDR). The paper details the timelines manufacturers should follow and who they must notify.

Earlier this year, the European Union adopted Regulation (EU) 2024/1860, which includes language in Article 10a requiring manufacturers to report potential product shortages under MDR and IVDR. On 30 October, the Commission published a paper outlining what manufacturers must do and when the legislation goes into effect early next year. (RELATED: Euro Roundup: EU updates MDR, IVDR to add obligations for companies facing supply problems, Regulatory Focus 11 July 2024)

The Commission noted that the amendments have three objectives, including giving IVD manufacturers and notified bodies more time to conduct conformity assessments under IVDR to prevent product shortages, and mitigating risks from potential IVD and medical device shortages by requiring shortage notifications to relevant competent authorities and health institutions. It also takes account of the gradual roll-out of the European database on medical devices (Eudamed), which should enable better monitoring of potential product shortages on the EU market. (RELATED: EU Council adopts amendments delaying IVDR deadlines, Regulatory Focus 30 May 2024)

The document addresses several key issues, including requiring manufacturers to report potential product shortages starting on 10 January 2025, though they are encouraged to begin sooner.

“Interruptions or discontinuations of the supply of a device anticipated by the manufacturer prior to this date, do not need to be reported, even if the interruption of discontinuation itself occurs after 10 January 2025,” the Commission added. “Nonetheless, manufacturers are encouraged to inform the users of their devices of supply interruptions or discontinuations on a voluntary basis before 10 January 2025, in line with existing best practices.”

The Commission also noted that manufacturers are solely responsible for informing stakeholders about anticipated interruptions and discontinuation of supplies of certain devices. They cannot delegate their product shortage notification responsibilities but can use authorized representatives, economic operators (EO), and third parties to implement the requirements.

“Once the notification is complete, it is the responsibility of the notified economic operators to cascade the information as provided by the manufacturer (without changing, adding to or paraphrasing this communication so as to preserve its integrity) to the downstream supply chain, including until it reaches health institutions or healthcare professionals as relevant,” it added.

The Commission said that manufacturers are required to notify economic operators, health institutions, and healthcare professionals who directly receive the devices about potential shortages. They are also similarly required to notify competent authorities of member states where the product is authorized if they expect a shortage.

“Manufacturers are not obliged, however, to inform those actors whom they do not directly supply,” the Commission said. “The responsibility for onward information sharing in the downstream supply chain lies with the EOs following the receipt of the information from the manufacturer or another EO.”

Another important factor is that manufacturers are expected to submit potential device shortage notifications to stakeholders at least six months before they happen. However, the document recommends that they don’t wait for the six-month deadline and instead alert stakeholders even earlier, if possible, especially if they plan to discontinue making the product.

“It is acknowledged that exceptional circumstances may prevent a manufacturer from meeting this requirement,” the Commission said. “Under such exceptional circumstances the manufacturer should inform the relevant actors without undue delay.”

“It is encouraged that the manufacturer has adequate processes and monitoring systems in place in order to fulfil its notification obligation in a timely manner,” it added.

The paper also addresses questions such as what is meant by “exceptional circumstances” where manufacturers are unable to give stakeholders a shortage notification six months in advance and
what factors could cause potential shortages.

European Commission Q&A paper

European Commission Q&A details shortage reporting requirements under MDR, IVDR

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