EU Article 10a MDR/IVDR Decision Tree for Marketing Interruption Notification
Summary
The European Commission published a decision tree to guide economic operators—including manufacturers and agents—on applying Article 10a of EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). The tool clarifies when ending or interruption of medical device or in vitro diagnostic marketing requires notification to FAMHP. Economic operators should use this decision tree to determine their reporting obligations before notifying the Belgian authority.
“The decision tree is intended as a tool to help economic operators (mainly manufacturers and agents) to determine in which cases a notification to the Federal Agency for Medicines and Health Products (FAMHP) is required in the event of ending or interruption of the marketing of medical devices and medical devices for in vitro diagnostic.”
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GovPing monitors Belgium FAMHP News for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 3 changes logged to date.
What changed
The European Commission released a decision tree under Article 10a of Regulations (EU) 2017/745 and 2017/746 to clarify when economic operators must notify FAMHP of ending or interruption of medical device or in vitro diagnostic marketing. The decision tree serves as an interpretive tool for manufacturers and agents to self-assess their notification obligations.
Medical device and in vitro diagnostic manufacturers and their agents operating in Belgium should use this decision tree to determine whether a notification to FAMHP is required before ceasing or interrupting device marketing. Failure to notify when required under Article 10a may constitute a regulatory non-compliance.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Medical devices and medical devices for in vitro diagnostics: decision tree for relevant actors on the application of Article 10a of the European regulations
date: 17/04/2026 When must an ending or interruption in the marketing of medical and in vitro diagnostic devices be notified? The European Commission recently published a decision tree to support the economic operators concerned.
The European Commission recently published a decision tree relating to Article 10a of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). When is it necessary to notify the ending or the interruption of the marketing of medical and in vitro diagnostic devices?
The decision tree is intended as a tool to help economic operators (mainly manufacturers and
agents) to determine in which cases a notification to the Federal Agency for Medicines and Health Products (FAMHP) is required in the event of ending or interruption of the marketing of medical devices and medical devices for in vitro diagnostic.
More information
Decision tree - Article 10a
Notification of ending or interruption of the supply of medical devices
Unavailability of health products - medical devices
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Last updated on
17/04/2026
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Source document text, dates, docket IDs, and authority are extracted directly from FAMHP.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
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