Structured dialogues and existing information
The Medical Device Coordination Group (MDCG) issued a new revision of MDCG 2019-6, Questions and answers: Requirements relating to notified bodies. In revision 5, certain questions have been added or updated. Importantly, section I.6 has been replaced by sections I.6.1 to I.6.3. This section lays out the details regarding structured dialogues with notified bodies. This process is essential to understand for manufacturers as structured dialogues are intended to help clarifying important questions on a device’s conformity assessment procedure upfront and thus safeguard a smoother certification. Furthermore, there are new details as to how existing information may be used to prevent duplicate work at notified bodies and manufacturers.
Article 10a, MDR and IVDR
Article 10a of the medical devices and in vitro diagnostic medical devices regulation (MDR and IVDR) was set up in the context of amending Regulation (EU) 2024/1860. It came into effect by January 10, 2025 and obliges manufacturers to inform in the event of a supply interruption or discontinuation. The European Commission has published a Q&A document and additional reporting forms. What was missing up so far is a decision flow chart. MedTech Europe has now set up a decision tree for manufacturers to “understand, interpret, and apply Article 10a MDR/IVDR in practice.” The document can be downloaded here.
Source: European Commission