May 18, 2022

Ask the Writers

Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies

In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, will outline the must-have elements for two very similar regulatory reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR).

Participants will understand the required and critical content that is common to both documents and learn best-practice writing strategies to support successful completion of these challenging projects. Come with your questions ready to get feedback from our experts!

Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.

This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.

Who is this forum for?

Those regulatory, quality and clinical leaders and teams who are tasked with the development, writing, review, or approval of Clinical Evaluation Reports for MDR submissions or Scientific Validity Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend.

Click here to register for this webinar.

Why is it important to establish state of the art during the clinical evaluation?

The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the state of the art, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis.

Establishing and describing state of the art is not an isolated task, but is central to the entire clinical evaluation. Defining the current, accepted best treatment options, and describing the risks and benefits of these options, provides essential information for multiple aspects of the clinical evaluation. Thus, establishing state of the art yields information that is essential for determining if the safety and performance of a device is compatible with current standards (in comparison to available treatment options). In other words, state of the art establishes a reference standard that is used throughout the clinical evaluation.

If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can download our full whitepaper.

Categories:
Do you like it?0
April 28, 2022

[Ask the Expert] Common Notified Body Review Findings

tips to avoid common notified body review findings

This session’s topic: Tips For How to Avoid Common Notified Body Review Findings

Criterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions based upon Notified Body review and feedback.  Addressing NB feedback costs your team time and effort and may threaten critical submission deadlines. However many of these issues might have been avoidable with thorough pre-planning, proper project scoping and asking the right questions from the beginning.  In this “Ask the Expert” question-and-answer session, we will show you some of the most common issues our writing team encounters with clients who face these revisions and discuss how they can be avoided. Presented from the perspective of experienced medical writers, we hope to provide examples of how solid planning during your own writing process can help you avoid the most common missteps in your own CER or PER.

During this 45-minute session, come prepared with your questions for our experts to answer regarding your notified body review findings. Please submit them ahead of time while registering so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.

This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.

Who is this forum for?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.

Register now for this LIVE session.

“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits

Notified Bodies (NBs) across Europe along with global manufacturers are facing resource constraints. The cause? Additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, the European notified body association, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines.

The primary concern cited is the likely device shortage for patients. More complex and longer certification processes required under MDR/IVDR are influencing this shortage. In conjunction, the demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs). With only 25 NBs for MDR and 6 for IVDR, the demand outweighs supply. Compared with 51 NBs designated for MDD and 21 under the AIMDD/IVDD Directives, manufacturers are in a tough situation now compared to years prior.

Team-NB identified the following four primary contributing factors, summarized in our recent blog post here.

Categories:
Do you like it?0
March 16, 2022

“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits

Author: Stacie Beecham

Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, the European notified body association, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines.

The primary concern cited is that Europe faces a likely device shortage for patients due to the more complex and longer certification processes required under MDR/IVDR. The demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs), with only 25 NBs for MDR, and 6 for IVDR, as compared with 51 NBs designated for MDD, and 21 under the AIMDD/IVDD Directives.

(more…)
Categories:
Do you like it?0
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.

(more…)
Categories:
Do you like it?0
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. 

(more…)
Categories:
Do you like it?0