In the ever-evolving landscape of medical device regulation, Clinical Evaluation Reports (CERs) play a pivotal role in ensuring compliance with the Medical Device Regulation (MDR). For Regulatory Affairs executives, the pressure to optimize the CER process is mounting as the industry demands more efficient strategies. This blog explores actionable strategies to streamline CERs, focusing on enhanced data synthesis and the use of structured templates, aimed at reducing feedback loops and approval times. 

The Importance of Efficient CERs 

Clinical Evaluation Reports are not just a regulatory requirement; they are a cornerstone in demonstrating the safety and performance of medical devices throughout their lifecycle. As the regulatory framework tightens, the need for precise and efficient clinical evaluation becomes more critical. Streamlining CERs can significantly impact the market success of a device by accelerating the path to compliance and market entry. 

Enhanced Data Synthesis 

One of the key strategies in streamlining CERs is the implementation of enhanced data synthesis. By leveraging advanced data analytics tools, companies can integrate and analyze clinical data more effectively. This approach not only improves the quality of the clinical evidence presented but also significantly reduces the time spent in preparing the report. 

Studies show that employing advanced data synthesis can reduce the preparation time of CERs by up to 30%, primarily by minimizing the need for manual data sorting and analysis (Journal of Medical Device Regulation). This not only speeds up the approval process but also enhances the robustness of the report, making it more likely to be accepted in the first round of regulatory review. 

Pressure Tested Templates 

The use of well-developed templates that have been pressure tested under notified body review is another effective tool in the CER process. Templates ensure that all regulatory requirements are systematically addressed, reducing the likelihood of missing crucial information. More importantly, they standardize the format and content within the report, streamlining the regulatory review process. This not only facilitates faster approvals but also decreases the number of feedback loops required, saving valuable time and resources. 

Training and Expertise 

Equipping your team with the right skills and knowledge is crucial. Continuous training in the latest regulatory requirements and report writing skills can significantly enhance the efficiency of your CER process. Partnering with experts who specialize in regulatory writing and clinical evaluations can also provide a significant advantage. 

Technology and Collaboration Tools 

Incorporating technology solutions such as collaborative platforms can enhance team efficiency by allowing seamless communication and real-time updates. These tools help in maintaining a cohesive workflow, especially when dealing with multiple stakeholders involved in the CER process. 

Conclusion 

Streamlining Clinical Evaluation Reports is essential for maintaining compliance with MDR and facilitating the successful launch of medical devices. By integrating enhanced data synthesis, utilizing structured templates, investing in ongoing training, and embracing technology, companies can significantly reduce the time and effort involved in preparing and processing CERs. As regulatory frameworks continue to evolve, staying ahead in efficiency can not only save time and costs but also substantially enhance the competitiveness of medical device companies in the global market. 

For more insights into optimizing your regulatory processes, visit Criterion Edge. 

Note: All metrics used in this blog are based on studies and industry reports. Links to these resources are provided for further verification and detailed information. 

May 28, 2024

How to Streamline Clinical Evaluation Reports for Medical Devices 

In the ever-evolving landscape of medical device regulation, Clinical Evaluation Reports (CERs) play a pivotal role in ensuring compliance with the Medical Device Regulation (MDR). For Regulatory Affairs executives, the pressure to optimize the CER process is mounting as the industry demands more efficient strategies. This blog explores actionable strategies to streamline CERs, focusing on enhanced data synthesis and the use of structured templates, aimed at reducing feedback loops and approval times. 

The Importance of Efficient CERs 

Clinical Evaluation Reports are not just a regulatory requirement; they are a cornerstone in demonstrating the safety and performance of medical devices throughout their lifecycle. As the regulatory framework tightens, the need for precise and efficient clinical evaluation becomes more critical. Streamlining CERs can significantly impact the market success of a device by accelerating the path to compliance and market entry. 

Enhanced Data Synthesis 

One of the key strategies in streamlining CERs is the implementation of enhanced data synthesis. By leveraging advanced data analytics tools, companies can integrate and analyze clinical data more effectively. This approach not only improves the quality of the clinical evidence presented but also significantly reduces the time spent in preparing the report. 

Studies show that employing advanced data synthesis can reduce the preparation time of CERs by up to 30%, primarily by minimizing the need for manual data sorting and analysis (Journal of Medical Device Regulation). This not only speeds up the approval process but also enhances the robustness of the report, making it more likely to be accepted in the first round of regulatory review. 

Pressure Tested Templates 

The use of well-developed templates that have been pressure tested under notified body review is another effective tool in the CER process. Templates ensure that all regulatory requirements are systematically addressed, reducing the likelihood of missing crucial information. More importantly, they standardize the format and content within the report, streamlining the regulatory review process. This not only facilitates faster approvals but also decreases the number of feedback loops required, saving valuable time and resources. 

Training and Expertise 

Equipping your team with the right skills and knowledge is crucial. Continuous training in the latest regulatory requirements and report writing skills can significantly enhance the efficiency of your CER process. Partnering with experts who specialize in regulatory writing and clinical evaluations can also provide a significant advantage. 

Technology and Collaboration Tools 

Incorporating technology solutions such as collaborative platforms can enhance team efficiency by allowing seamless communication and real-time updates. These tools help in maintaining a cohesive workflow, especially when dealing with multiple stakeholders involved in the CER process. 

Conclusion 

Streamlining Clinical Evaluation Reports is essential for maintaining compliance with MDR and facilitating the successful launch of medical devices. By integrating enhanced data synthesis, utilizing structured templates, investing in ongoing training, and embracing technology, companies can significantly reduce the time and effort involved in preparing and processing CERs. As regulatory frameworks continue to evolve, staying ahead in efficiency can not only save time and costs but also substantially enhance the competitiveness of medical device companies in the global market. 

For more insights into optimizing your regulatory processes, visit Criterion Edge. 

Note: All metrics used in this blog are based on studies and industry reports. Links to these resources are provided for further verification and detailed information. 

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May 2, 2024

IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR

While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER).

To help manufacturers prepare and comply with the IVDR, we have compiled some tips for developing and implementing a successful PEP as you prepare for your IVDR submissions.

Learning Objectives: 

  • Describe the scope and objectives of the PEP, including considerations to identify the clinical claims, the target population, the clinical conditions, the comparators, and the endpoints.
  • Review how to conduct a comprehensive systematic literature review, a critical component of the PEP which provides the basis for the clinical evidence, both favorable and unfavorable.
  • Discuss strategies to prepare a detailed scientific validity report (SVR), a new requirement under the IVDR to provide a clear rationale and scientific justification for the choice of the analyte or marker, as well as the evidence of its association with the clinical condition or physiological state.
  • Define the requirements of the analytical performance report (APR), another new requirement under the IVDR which seeks to demonstrate the analytical performance of the IVD in terms of its ability to correctly measure the analyte or marker.
  • Clarify the expectations for sufficient clinical data contained within the clinical performance report (CPR), a key requirement under the IVDR that demonstrates the clinical performance of the IVD in terms of its ability to correctly identify or predict the clinical condition or physiological state of the target population
Click here to reserve your spot for the webinar.

Who is this webinar for?

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions.

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June 23, 2023

It’s All Interconnected: Hidden Traps That Can Derail Your PER

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).  

This presentation provides practical tips on how to assess for hidden traps and unexpected roadblocks that could impact the success of writing an IVDR-compliant PER. By performing a gap analysis and assessing the readiness and availability of critical resources, documents and expertise, you will be able to avoid project delays and discover efficiencies that will enable the on-time completion of a successful, IVDR-compliant PER. 

Learning Objectives: 

  • The importance of scoping your PER project in advance  
  • The critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete  
  • How to identify those hidden gaps in resources and information and the steps to take to mitigate them

Click here to watch the webinar recording and download the presentation slides.

Who is this webinar for?

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions.

Ask the Expert: Plain Language Written Content for Multiple Audiences: Effective Communication for Patients, Caregivers, and HCPs

Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written content ensures key health information and clinical research findings are understandable and accessible to all.

Click here to watch this recent webinar to learn key elements of plain language written content, how to identify the target audience, selecting the most appropriate dissemination channels for the information, the challenges to produce a multitude of plain language written deliverables for multiple audiences, and more.

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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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February 7, 2022

[Ask the Expert] Safety and Performance (MDR)

This session’s topic: Safety and Performance Measures and Acceptance Criteria for MDR

Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk?

This is a 45-minute Q&A session during which President Laurie Mitchell will answer questions like these and more. Submit your questions when you register for this forum. Please be aware that answers will be limited to 3 minutes per questions. This forum will operate on a first come first serve basis.

Who is this forum for?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Clinical Evaluation Reports for EU MDR submissions

Click here to watch the recording.

Clearly Defining Measurable Safety and Performance Endpoints

The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations.  

These relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently, medical device manufacturers felt the pressure to comply by May 2021.

Read more on this topic in our blog post, here.

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