Why Clinical Evaluation Reports (CERs) Are Challenging and How BioBoston Consulting Can Simplify the Process

Clinical Evaluation Reports (CERs) are essential documents for medical device manufacturers seeking regulatory approval—particularly under the EU Medical Device Regulation (EU MDR). These reports provide crucial evidence demonstrating that a device meets stringent safety and performance requirements. However, creating and maintaining CERs is often complex, resource-intensive, and fraught with challenges. 

In this article, we explore why CER preparation can be so demanding for medical device companies and how BioBoston Consulting helps streamline the entire process with expert regulatory guidance and innovative solutions. 

 

The Complexity of Clinical Evaluation Reports Under EU MDR 

Navigating an Evolving Regulatory Landscape 

One of the primary hurdles in CER development is keeping pace with constantly evolving regulations. The EU MDR introduced stricter requirements for clinical evidence, particularly affecting higher-risk devices. Manufacturers must continuously monitor changes to regulations, Notified Body expectations, and post-market surveillance (PMS) obligations. 

Maintaining compliance means gathering and updating clinical data regularly, including post-market clinical follow-ups (PMCF), which adds layers of complexity and ongoing responsibility. 

Challenges in Clinical Data Collection and Literature Reviews 

Collecting sufficient, high-quality clinical data for CERs can be difficult, especially for: 

• Legacy or well-established devices 

• Low-risk devices lacking extensive clinical studies 

• Devices used in combination with other products 

Conducting a comprehensive systematic literature review requires access to multiple databases and expertise to identify and appraise relevant clinical studies. This process demands both time and specialized knowledge to meet regulatory standards and fully support device safety and efficacy claims. 

 

How Long Does It Take to Prepare and Update a CER? 

According to MEDDEV 2.7.1 Rev 4, clause 6.2.3, CER updates should occur: 

• Annually for high-risk or new devices 

• Every 2 to 5 years for low-risk or well-established devices 

Updates may also be necessary when: 

• New post-market data impacts the benefit-risk profile 

• Device design or manufacturing changes affect safety/performance 

• New risks are identified from emerging literature or data sources 

Manufacturers must evaluate these triggers to determine appropriate CER update schedules. 

 

How BioBoston Consulting Simplifies CER Development and Compliance 

At BioBoston Consulting, we recognize the intricate regulatory demands facing medical device manufacturers. Our regulatory experts provide customized consulting services that help clients navigate CER preparation with confidence and efficiency. 

Expertise You Can Trust 

• Up-to-date knowledge of EU MDR requirements and Notified Body expectations 

• Tailored CER strategies based on your device’s risk classification and market 

• Support for clinical data gathering, literature reviews, and post-market surveillance planning 

AI-Enabled Tools for Efficient Literature Reviews 

Leveraging cutting-edge, AI-driven technologies, BioBoston Consulting helps clients streamline the labor-intensive literature review process, ensuring comprehensive and compliant clinical evaluations without compromising quality or timelines. 

Flexible, Scalable Solutions for Every Manufacturer 

We understand that no two manufacturers have identical needs. Whether you require end-to-end CER development or support with specific elements like literature reviews or PMCF, BioBoston Consulting offers scalable solutions that adapt to your unique challenges and budget. 

Our approach also focuses on cost optimization—helping reduce long-term compliance expenses through process improvements and technology integration. 

 

Conclusion: Streamlining CERs for Faster Market Access and Regulatory Confidence 

Preparing compliant Clinical Evaluation Reports is a demanding but essential part of medical device regulatory submissions under the EU MDR. With the right expertise, tools, and strategic approach, manufacturers can overcome these challenges efficiently. 

Partner with BioBoston Consulting to gain access to experienced regulatory professionals, AI-powered solutions, and tailored support designed to accelerate your CER process, enhance compliance, and ensure successful regulatory outcomes. 

 

Ready to Simplify Your Clinical Evaluation Reports? 

If you are struggling with CER development or want to improve your regulatory submission strategy, contact BioBoston Consulting today. Let us help you navigate the complexities of CER preparation, achieve EU MDR compliance, and accelerate your path to market success.