February 25, 2022

Expert Opinion Panels and New Guidance Documents Are Part of the Changing Landscape of MDR 2017/745

Author: Suzanne Broussard, PhD  | February 25, 2022

The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights included compliance dates, expert opinion panels, newly published guidance and standards. 

MDD Grace Period Extension

The original deadline of 26 May 2021 for MDR 2017/745 compliance has come and gone, and many medical device manufacturers with devices granted a CE mark under MDD are taking advantage of the 26 May 2024 grace period to become fully complaint with MDR. As of September 2021, the EU notified bodies had granted only 502 conformity assessment certificates, thus, it is anticipated there will be an extreme bottleneck in 2023 and especially in 2024 due to limited notified body availability as manufacturers scramble to meet the May 2024 deadline.

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January 20, 2022

[FREE WEBINAR] Post-Market Literature Surveillance: Systematic Literature Review and Case Study

Click here to watch the recording of this webinar.

Joining Criterion Edge’s President Laurie Mitchell, is guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions​. In this webinar, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance, and share best tips on a robust systematic literature review process. Following this, our guest speaker shares an informative case study illustrating more.

Key Takeaways:

  • How leveraging published data can help meet regulatory expectations and inform internal decision-making​
  • Steps for conducting a methodologically-sound SLR​
  • How data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies and support regulatory compliance. 

Who Should Watch:

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.

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

Queenita Fernandes, Medical Safety Manager | Medtronic

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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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August 26, 2021

[FREE WEBINAR] Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

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This webinar is presented from the point of view of seasoned MDR-compliant CER medical writers. Criterion Edge discusses strategies for the verification of device safety and performance in the clinical evaluation. Next, we teach you how to identify meaningful safety and performance measures for the clinical evaluation and define parameters to determine the acceptability of benefit-risk.

Key Takeaways:

Based on the state-of-the-art

  • Identify meaningful safety and performance endpoints (measures/objectives) 
  • Demonstrate that safety and performance objectives are appropriate and clinically relevant 
  • Specify acceptance criteria that are used to determine the acceptability of benefit-risk 

Who Should Watch:

Those Regulatory, Quality and Clinical leaders and regulatory writers who develop, write, review or approve Clinical Evaluation Reports for EU MDR submission. Additionally, anyone interested in learning more about MDR requirements for CERs is encouraged to watch as well. Finally, we encourage viewers from the IVD industry as well, as the content is relevant to IVDR requirements, which align closely with MDR. 

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

Sign up for future webinars or view our events calendar.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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June 8, 2021

IVDR Compliance: Insights Gained from Writing MDR-Compliant CERs that Can Be Leveraged to Meet IVDR Requirements

Author: Suzanne Broussard, PhD  | June 8, 2021

In vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes in IVD classification will require the majority of IVDs currently marketed in the EU to undergo notified body scrutiny under IVDR and obtain CE marking, yet few guidance documents have been released. Lessons learned from meeting Medical Device Regulation (MDR) 2017/745 can help pave the way.  

Here we share our insights learned from writing many MDR-compliant Clinical Evaluation Reports (CERs) in the context of IVD medical devices and the looming IVDR deadline. 

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May 24, 2021

[FREE WEBINAR SERIES] How to Assess Your CER for MDR Readiness

In the first installment of this webinar series, Criterion Edge presents strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. This practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.

In the second installment, we continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, examining the clinical data sources, equivalence, and risk/benefit analysis profile sections of the CER.

Finally, in the third presentation we share with you some of the biggest issues we have discovered when starting an MDR CER project based on our experiences with clients both large and small, and we also reveal some of the most successful strategies in addressing these issues, up-front and early.

Click here to watch our free webinar series to develop MDR-ready CERs.

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