MDR/IVDR Watch / Archive
New measures to make EU health sector more innovative, competitive and resilient
Published 16 Dec 2025
The Commission announces new measures aimed at making the EU health sector more innovative, competitive and resilient. The headline does not specify whether medical devices or IVDs are directly affected, so the relevance to device manufacturers is unclear from the text provided.
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New MDCG guidance, implementing acts, standards and EUDAMED changes, each explained in two lines: what changed and who must act.
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Deadline 28 May 2026
The Commission states that the first four EUDAMED modules will be mandatory to use from 28 May 2026. The notice does not name the four modules, so teams should check the Commission's EUDAMED pages to confirm which ones apply to their device and economic-operator role.
Published 01 Dec 2025
The Commission published the overview presentation and results of the second economic operator survey (data status 31 October 2024) from the study monitoring availability of medical devices on the EU market. The results cover manufacturers, authorised representatives, importers and distributors, including separate findings for medical devices and IVDs. Relevant mainly for context on supply availability monitoring; no compliance action is stated.
Published 15 Dec 2025
MDCG published guidance on the breakthrough device (BtX) designation under the MDR and IVDR, covering breakthrough criteria, pre-clinical and clinical evidence expectations, PMCF/PMPF, expert panel and early-advice procedures, notified body responsibilities and support for SMEs. The document is non-binding and manufacturers seeking breakthrough status should review the criteria and evidence expectations.
Published 19 Jan 2026
The Commission has published a factsheet on the EU medical device rules, aimed at explaining the benefits of the MDR and IVDR for patients. It is general background material with no new obligations for manufacturers.
Published 19 Dec 2025
MDCG 2025-10 provides guidance on the post-market surveillance (PMS) system and PMS plan under MDR and IVDR, covering main PMS activities, interactions with other QMS elements, and an annex overview of PMS obligations. It excludes detailed PSUR preparation, which is covered by MDCG 2022-21, and the health institution exemption under Article 5(5). Manufacturers should review their PMS systems and plans against this guidance.