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EU Notified Body Timelines: New MDR & IVDR Rules for Predictable CE Marking
The European Commission has adopted Implementing Regulation (EU) 2026/977, establishing harmonized and binding timelines for Notified Body conformity assessments under the MDR and IVDR. This episode details the new maximum timelines for key review stages—such as the 90-day limit for technical documentation assessment—and new rules for cost transparency. We explore how this regulation, adopted on May 4, 2026, provides greater predictability for manufacturers in their CE marking process, addressing long-standing industry concerns about inconsistent and lengthy review periods. Key Questions: -…
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