MDR/IVDR Watch / Archive
Implementing Regulation (EU) 2026/977: uniform requirements for notified bodies' conformity assessment
Deadline 25 Feb 2027 Published 18 May 2026
Implementing Regulation (EU) 2026/977, published in the OJEU on 5 May 2026, sets uniform requirements for notified body conformity assessment: quotations, timelines and clock-stops, cost and duration monitoring, and re-certification procedures. It applies from 25 February 2027, except the annual timelines/costs report, which applies from 1 January 2028. Manufacturers should expect changes in notified body processes and should plan for quotations and timelines under the new rules.
Original title: New Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies
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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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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.