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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:
- What is EU Implementing Regulation 2026/977 and why was it created?
- What are the new maximum timelines for Notified Body conformity assessments under the MDR and IVDR?
- How does the 90-day limit for technical documentation review impact CE marking strategy?
- What do the new rules on cost transparency mean for manufacturers?
- How can manufacturers leverage these changes to improve their product launch planning?
- What happens if a manufacturer's submission is incomplete and the review clock is stopped?
- How should regulatory teams adjust their internal processes in response to this regulation?
- What are the key obligations for Notified Bodies under these new rules?
Sources:
- https://www.medtecheurope.org/news-and-events/news/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/
- https://www.jdsupra.com/legalnews/recent-eu-and-uk-medical-devices-8924156/
- https://www.decomplix.com/medical-device-regulatory-affairs-news/
How Pure Global can help:
Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies navigating complex global markets. We help manufacturers adapt to new requirements like the EU's harmonized Notified Body timelines by developing efficient regulatory strategies and preparing high-quality technical dossiers to avoid delays. Our combination of local experts in over 30 markets and advanced AI technology streamlines the submission process, ensuring your products get to market faster. For support with your CE marking strategy or global expansion, visit us at https://pureglobal.com, contact us at [email protected], or explore our free AI tools and device database at https://pureglobal.ai.
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By Pure GlobalThe 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:
- What is EU Implementing Regulation 2026/977 and why was it created?
- What are the new maximum timelines for Notified Body conformity assessments under the MDR and IVDR?
- How does the 90-day limit for technical documentation review impact CE marking strategy?
- What do the new rules on cost transparency mean for manufacturers?
- How can manufacturers leverage these changes to improve their product launch planning?
- What happens if a manufacturer's submission is incomplete and the review clock is stopped?
- How should regulatory teams adjust their internal processes in response to this regulation?
- What are the key obligations for Notified Bodies under these new rules?
Sources:
- https://www.medtecheurope.org/news-and-events/news/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/
- https://www.jdsupra.com/legalnews/recent-eu-and-uk-medical-devices-8924156/
- https://www.decomplix.com/medical-device-regulatory-affairs-news/
How Pure Global can help:
Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies navigating complex global markets. We help manufacturers adapt to new requirements like the EU's harmonized Notified Body timelines by developing efficient regulatory strategies and preparing high-quality technical dossiers to avoid delays. Our combination of local experts in over 30 markets and advanced AI technology streamlines the submission process, ensuring your products get to market faster. For support with your CE marking strategy or global expansion, visit us at https://pureglobal.com, contact us at [email protected], or explore our free AI tools and device database at https://pureglobal.ai.