Latest Regulatory Updates on Medical Devices: What You Need to Know to Stay Compliant
The medical devices sector is constantly evolving, driven by both technological advancements and the regulatory complexity governing the market.
Adding to the complexity is the fact that medical devices are sometimes subject to intersecting regulations, such as Regulation (EU) 2017/745 (MDR), the body of rules on personal data protection, or the “Machinery” Directive. This interplay makes it essential for industry operators to stay continually updated. Below is a concise summary of the most recent regulatory developments.
MDCG 2023-3 Rev. 1: Clarifications on Vigilance Terms in MDR and IVDR
Originally published in February 2023, MDCG 2023-3 was recently revised in November 2024. This update aims to provide greater clarity on key terms used in the context of vigilance under both the MDR and IVDR, while adding new practical examples and frequently asked questions. Key highlights of the revision include:
- The definition of “incident” under Article 2(67) IVDR, with particular focus on what qualifies as “harm caused by a medical decision, action, or omission based on the information provided by the device” and how to manage such cases in the context of vigilance.
- An explanation of the term “expected erroneous result” and related management procedures.
- Guidance on how to report corrective safety actions undertaken in third countries to the competent authorities, as required under Articles 87(2)(b) MDR and 82(1)(b) IVDR.
- Instructions on managing serious incidents involving CE-marked devices used in clinical investigations or performance studies.
MDCG 2024-15: Publication of Clinical Investigation Reports Without Eudamed
Article 77(5) of the MDR mandates that sponsors of clinical investigations submit a full clinical investigation report and a summary of the study to national authorities within one year of the study’s conclusion or, in the case of early termination, within three months.
However, since Eudamed is not yet fully operational, MDCG 2024-15 provides practical guidelines on how to fulfill these obligations by using the temporary platform CircaBC, as previously indicated in MDCG 2021-1 Rev. 1.
Obligation to Notify in Case of Supply Interruption of Medical Devices
With the entry into force of Regulation 2024/1860 in January 2025, manufacturers must fulfill a new obligation: promptly informing competent authorities and healthcare institutions if the supply of certain medical devices or in-vitro diagnostic devices is expected to be interrupted or discontinued.
This requirement specifically applies when such interruptions could reasonably be expected to cause serious risks to patients or public health.
The Q&A published in October 2024 provides detailed answers regarding:
- The types of devices subject to this obligation.
- Specific requirements for manufacturers and notification procedures.
- Key terminology to ensure proper application of the regulation.
Additionally, the regulation introduces the concept of a gradual roll-out of Eudamed, allowing platform modules to become operational progressively. The European Commission has issued a specific document to clarify timelines, obligated parties, and operational modalities for registering devices in the European market.
The regulatory landscape for medical devices is becoming increasingly complex and rapidly evolving. Recent updates from the MDCG and new obligations under Regulation 2024/1860 represent crucial steps towards greater safety, traceability, and transparency.
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