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A new reporting requirement under (EU) 2024/1860 comes into force in a few days’ time, on 10th January 2025. The circumstances for reporting are when:
- A legal manufacturer anticipates there will be a reasonably foreseeable interruption (more than 60 days) or discontinuation of supply.
and
- The shortage could result in serious harm or a risk of serious harm to patients or public health in one or more Member States.
Under these requirements any medical device or in vitro medical device legal manufacturer must communicate the anticipated interruption or discontinuation of supply to
- The Competent Authority (where they or their Authorised Representative is based) at least 6 months beforehand, unless there are exceptional circumstances, and provide the reason/s for the interruption or discontinuation.
- All economic operators (Authorised Representative, Importer and Distributors), health institutions and healthcare professionals to whom it directly supplies.
The potential reasons for an anticipated interruption or discontinuation include but are not limited to:
- Regulatory
◦ Loss of compliance under Article 120 (MDR) / Article 110 (IVDR)
◦ Delay in certification
◦ Suspension or withdrawal of certification
◦ Decision not to pursue MDR / IVDR certification
- Manufacturing
◦ Device performance issues
- Supply Chain
◦ Shortage of raw materials / components
- Other
◦ Marketing or business reason
◦ Event e.g. natural disaster outside of manufacture’s control
Additional information can be found in the European Commission Q&A publication (Q&A – Regulation (EU) 2024/1860 Article 10a MDR and IVDR) and templates to be used are located in MDCG 2024-16 and MDCG 2024-16 Annex Device Identification table.
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.