ARTICLE SUMMARY:
In this edition of Consultants Corner, industry, legal, and notified body experts detail significant open questions and provide tips to prepare as best as possible for an impending European requirement that companies disclose anticipated device shortages.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
Device companies operating in Europe will be required to report anticipated product shortages to EU country authorities and customers starting in January. But with less than four months to go, basic questions about the what, when, and how these reports should be made, and the implications of passing along this information, remain unanswered, device industry experts say.
EU lawmakers officially appended the new “obligations in case of interruption or discontinuation of supply of certain devices” to the EU Medical Device and IVD Regulations this summer as part of a collection of reforms. The new requirements are meant to put the government in a better position to respond to shortages in the aftermath of the COVID-19 pandemic and as a significant swath of companies have withdrawn or plan to withdraw certain devices rather than transitioning them to the new regulations.
The provisions, which officially take effect January 10, 2025, state that a manufacturer must inform the competent authority of the country where it (or its EU authorized representative) is based when it anticipates a supply stoppage that “could result in serious harm or a risk of serious harm to patients or public health” six months in advance of the “interruption or discontinuation.” In addition, the company must inform “economic operators, health institutions, and healthcare professionals to whom it directly supplies the device.”
The updated rules also require the competent authority to tell authorities from all the other EU member states about the expected shortage. And economic operators, such as distributors or other device companies, that are informed of an anticipated shortage by the manufacturer must pass the information along to anyone to whom they provide the device.
The European Commission has tasked the Medical Device Coordination Group to develop a Q&A guidance document to help explain how the requirements should be implemented. But that has yet to be published and, as it stands now, companies are left in the dark about how to square these new mandates with the complicated dynamics of the medical device supply chain, experts lamented during a September 12 webinar convened by the consulting firm RQM+. Here’s a look at a few of the central outstanding questions about the oncoming requirements and some tips from the experts on what companies can try to do to prepare.
