{"id":33322,"date":"2024-11-22T11:49:17","date_gmt":"2024-11-22T10:49:17","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/11\/22\/carenze-di-dispositivi-medici-domande-e-risposte-sullarticolo-10a-del-regolamento-ue-2024-1860\/"},"modified":"2024-11-22T12:08:04","modified_gmt":"2024-11-22T11:08:04","slug":"carenze-di-dispositivi-medici-domande-e-risposte-sullarticolo-10a-del-regolamento-ue-2024-1860","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/11\/22\/carenze-di-dispositivi-medici-domande-e-risposte-sullarticolo-10a-del-regolamento-ue-2024-1860\/","title":{"rendered":"Shortages of Medical Devices: Questions and Answers on Article 10a of Regulation (EU) 2024\/1860"},"content":{"rendered":"

22\/11\/2024<\/h2>\n

The European Commission<\/strong> has recently published a document entitled ‘Q&A Obligation to inform in case of interruption or discontinuation of supply<\/strong>‘ (October 30, 2024), which clarifies the responsibilities of manufacturers regarding the reporting of potential shortages of medical devices.<\/h2>\n

The clarifications concern Article 10a of Regulation (EU) 2024\/1860 of June 13, 2024<\/strong>, which, among other aspects, establishes the obligation for manufacturers to inform the competent authorities<\/strong> and other relevant parties in the event of interruption or termination of the supply of medical devices, except for custom-made devices. The regulation applies in the case of devices for which discontinuation or cessation could cause serious harm<\/strong> or risk of serious harm<\/strong> to patients or public health.<\/p>\n

The Q&A document offers practical details for the implementation of this provision, which will come into force on January 10, 2025<\/strong>. First of all, regarding timing, as stated in the answer to the first question: “interruption or cessation of supply of a device planned by the manufacturer before this date (January 10, 2025) need not be reported<\/strong>, even if the interruption or cessation itself occurs after January 10, 2025. However, manufacturers are encouraged to voluntarily inform users of their devices in case of discontinuation or cessation of supply before January 10, 2025, in line with existing best practices.<\/p>\n

Manufacturers’ Obligations and Communication Chain
\nDuring the transition period of the MDR and IVDR Regulations, significant problems emerged due to the interruption of the supply of medical devices, putting continuity of care for patients at risk. Consequently, the new regulation requires manufacturers to inform:<\/p>\n

    \n
  1. The competent authority of the Member State<\/strong> where the manufacturer or its authorised representative is established.<\/li>\n
  2. Economic operators<\/strong> (distributors, importers, etc.), healthcare<\/strong> institutions<\/strong> and healthcare professionals<\/strong> to whom the device is directly supplied.<\/li>\n<\/ol>\n

    Notification must take place at least<\/strong> six months before<\/strong> the planned interruption or termination<\/strong>, except in cases of exceptional circumstances.<\/p>\n

    One of the questions addressed in the Q&A concerns precisely the definition of ‘exceptional circumstances<\/strong>‘, specifying the conditions under which the six-month notice period can be reduced. Exceptional circumstances occur when the manufacturer is unable to foresee or confirm the interruption or cessation of supply at least six months before the start of the event; this may include unforeseen situations, such as natural disasters or difficulties in the supply of raw materials.<\/p>\n

    Furthermore, the document recommends not to wait until the six-month deadline but to notify interested parties even earlier, if possible, especially if there is an intention to discontinue production of the device.<\/p>\n

    The competent authorities<\/strong>, upon receipt of the notification, are obliged to inform the other Member States and the European Commission without delay. Manufacturers<\/strong> must ensure that this information is communicated promptly to all actors involved in the distribution chain.<\/p>\n

    Some Q&A<\/h2>\n

    The Q&A document answers 14 key questions, among which, in addition to those already mentioned in the previous paragraphs, it includes:<\/p>\n

    \u2022<\/strong> Who is subject to the obligation of Article 10a?<\/strong> The obligation applies to all manufacturers of medical devices subject to the MDR and IVDR.<\/p>\n

    \u2022 What is the notification procedure?<\/strong> Notifications must be in writing, including the reasons for the interruption.<\/p>\n

    \u2022<\/strong> To which ‘certain devices’ does Article 10a(1) of MDR\/IVDR apply?<\/strong>
    \n“Except for custom-made devices, Article 10a of the MDR\/IVDR shall, as of its date of application, January 10, 2025, apply to all models or types of devices placed on the Union market for which it is reasonably foreseeable that an interruption or discontinuation of supply could cause serious harm or a risk of serious harm to patients or public health in one or more Member States.”<\/p>\n

    \u2022<\/strong> What is meant by ‘anticipation of an interruption or termination’ of the supply of a device as provided for in Article 10a(1) of MDR\/IVDR?<\/strong>
    \n“Interruption of supply is understood as a temporary inability to place devices of a given model or type on the Union market, with an expected duration of more than 60 days. ‘Termination of supply’ indicates when the manufacturer decides to definitively cease supplying a device.<\/p>\n

    Impact on the Sector<\/h2>\n

    The introduction of Article 10a is intended to improve the transparency and preparedness of health authorities for potential shortages of critical medical devices. Manufacturers must adopt effective monitoring and reporting systems<\/strong> to comply with the new obligation.\u00a0 The Q&A also emphasises that notifications must be part of an integrated management approach, including contingency plans. With these measures, the aim is to protect the health of patients<\/strong> and ensure a quick and effective response in the event of supply disruptions. Manufacturers are called upon to respond promptly.<\/p>\n

    Link to the Guidance with all Q&As<\/strong><\/a><\/p>\n

    >>> <\/strong>Thema can provide comprehensive support<\/strong><\/a> in fulfilling the regulatory requirements of Regulation (EU) 2024\/1860, as well as the MDR and IVDR Regulations, ensuring compliance for the European market.<\/p>\n","protected":false},"excerpt":{"rendered":"

    22\/11\/2024 The European Commission has recently published a document entitled ‘Q&A Obligation to inform in case of interruption or discontinuation of […]<\/p>\n","protected":false},"author":115,"featured_media":33298,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-33322","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"\nShortages of Medical Devices: Questions and Answers on Article 10a of Regulation (EU) 2024\/1860 - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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