March 1, 2022

[FEATURED] Pharma, Device Groups Oppose FDA’s Planned Drug to Device Transition

Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to devices, in implementing a recent court decision.

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October 14, 2021

[FEATURED] How The MDR Is Making The EU Competitively Backward

Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.


When it comes to guidances supporting the implementation of the Medical Device Regulation, major issues are being created because there is “no real possibility for industry to actively and meaningly engage in drafting EU guidances” and provide input on how to make the new system work efficiently, Elizabeth Gfoeller, corporate director, regulatory affairs at MED-EL, an EU manufacturer of globally marketed hearing loss solutions, told the first day of the meeting on 13 September.

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October 12, 2021

[FEATURED] EN ISO 13485 Linked To MDR and IVDR At Last

Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.


The European standards bodies, CEN and Cenelec, have published an update to the EU medical quality management system standard to link it for the first time with the new Medical Device and IVD Regulations.

EN ISO 13485:2016+A11:2021 features new annexes demonstrating the link between specific clauses of the standard and the general safety and performance requirements (GSPR) of the MDR and IVDR.

An EN ISO standard is an international standard that has been adopted at the level of the EU. The differences are outlined in the foreword and annexes to the EU document which make the link with EU requirements.

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July 9, 2020

[FREE WEBINAR] How to Assess Your CER for MDR Readiness, Part 2: Clinical Data Sources, Equivalence, and Risk/Benefit Analysis

Get a copy of the slides from this webinar or click to watch the recording.

In this second part of our 2-part webinar series, Criterion Edge will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience authoring MedDev rev. 4 and MDR-compliant CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities. In this series, we will examine the Clinical Data Sources, Equivalence, and Risk/Benefit Analysis Profile sections of the CER. 

In the first webinar of this series, we discussed the State of the Art, Safety & Performance Criteria, Equivalence, and Systematic Literature Review.
Click here to get the slides and watch the recording for part 1.

Key Takeaways:
• Understand the key components of a clinical evaluation report (1-min review of last webinar, clinical evidence, SLR, risk benefit, conclusion – have you ensured that your conclusion reflects conclusions from other sections/data?) 
• Determine how to evaluate your CER for key requirements of the MDR 

Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.

Sign up for future webinars here.


If you enjoyed this webinar and would like a free consultation, please contact us here.

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June 5, 2020

[FREE WEBINAR] Live Q&A Follow-Up: How to Assess Your CER for MDR Readiness, Part 1

Q&A Follow Up with Laurie

Click here to watch the recording.

We had such a large turnout at our previous webinar, How to Assess Your CER for MDR Readiness, Part 1, and left with some questions unanswered. Therefore, President Laurie Mitchell held a live Q&A to respond to questions regarding CER for MDR Readiness. In this webinar, Laurie delves deeper into some of your pressing questions like:

  • Would you recommend using clinical data from systematic reviews and meta-analyses to support the safety and performance of the subject device? 
  • Do you compare warnings and precautions as part of clinical equivalence? 
  • Can you give an example of a safety/performance objective and corresponding acceptance criteria?  

Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.

Sign up for future webinars here.


If you enjoyed this webinar and would like a free consultation, please contact us here.

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