MDR/IVDR Watch / Archive
Harmonised standards under MDR/IVDR: new OJEU references and standardisation request M/575 amendments
Published 17 Jun 2026
The Commission page lists new Official Journal references for harmonised standards under MDR (2017/745) and IVDR (2017/746), including Implementing Decisions (EU) 2026/1231 (11 June 2026) and 2026/1313 (15 June 2026). Standardisation request M/575 was amended in January 2023 (Amd 1) and May 2024 (Amd 2). Manufacturers should check the listed standards against their current compliance approach, as the presumption of conformity applies only once references are published.
Original title: New harmonised standards for the Regulations on medical devices
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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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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 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.
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.