If you are preparing to launch your medical device in the European Union (EU) or already hold a CE Mark, you have likely come across the term Clinical Evaluation Report (CER). But what exactly is a CER, and how has it evolved under the new EU Medical Device Regulation (MDR)?
At BioBoston Consulting, we help medical device companies build fully compliant CERs that support market access, regulatory approval, and long-term device success in the EU.
From MDD to MDR: The Evolution of the CER
CERs have existed since the Medical Device Directive (MDD), but the introduction of EU MDR 2017/745 has transformed the expectations dramatically.
In the past, manufacturers could use clinical equivalence to justify device safety and performance using data from similar devices, even from other manufacturers. Now, under EU MDR, equivalence claims require a strict one-to-one match of biological, technical, and clinical characteristics—plus a legal agreement to access the comparator device’s clinical data.
In other words, if you do not have legal access to the clinical data of a similar device, it cannot be used to support your CER.
What Is a Clinical Evaluation Report (CER) Under EU MDR?
A CER is a detailed, evidence-based document that demonstrates the ongoing safety and clinical performance of your medical device throughout its lifecycle. It integrates data from various departments, including:
- Clinical evaluations
- Risk management
- Post-market surveillance (PMS)
- Post-market clinical follow-up (PMCF)
It is also a living document—meaning updates are required, often annually or biennially, depending on the classification of the device (Class IIa, IIb, or III).
🔎 At BioBoston Consulting, we build fully integrated CERs tailored to your device class, market strategy, and available clinical data—ensuring regulatory success.
Start with a Solid Clinical Evaluation Plan (CEP)
Every strong CER begins with a Clinical Evaluation Plan (CEP). This document defines the scope and structure of your evaluation, helping you identify potential gaps and outline your evidence-gathering strategy.
Key planning questions include:
- What is the classification of the device?
- Is this a legacy device or newly developed?
- Who is the target patient population?
- What clinical data exists today?
- Are all intended uses and indications supported?
A well-constructed CEP sets the foundation for a successful CER by helping you navigate data needs, study requirements, and the state of the art (SOTA).
The Role of Clinical Data in a CER
The clinical data forms the core of your CER. This includes:
- Clinical trial results conducted by your company
- Systematic literature reviews
- Real-world evidence
- Post-market surveillance (PMS) and PMCF data
Note: Data from similar devices cannot be used unless the equivalence criteria and legal access requirements are fully met under MDR.
At BioBoston Consulting, our team specializes in systematic literature reviews, gap analysis, and data synthesis to generate objective, regulator-ready evidence for your device.
Benchmarking with State of the Art (SOTA)
To demonstrate acceptable risk/benefit profiles, you must compare your device against the state of the art—which includes other devices with similar indications, features, and clinical use cases.
SOTA sets the performance and safety benchmarks your device must meet or exceed. This requires:
- Careful selection of comparator devices
- Literature-backed justification
- Clearly defined clinical endpoints and outcomes
SOTA is more than just industry best practice—it is the standard your CER will be measured against. Let BioBoston Consulting guide you through this critical element with expertise and clarity.
Tips for Creating a Successful CER
Every device is different, and so is every CER. Here are several strategies we recommend:
- Segment CERs by product family: Avoid combining devices with vastly different applications, designs, or user profiles in one report.
- Focus on meaningful benchmarks: Stick to safety and performance outcomes supported by strong clinical evidence.
- Plan updates according to classification: Class III and implantable devices require more frequent updates—often annually.
- Leverage PMCF data: Ongoing clinical data collection helps reinforce claims and reduce future regulatory risk.
✅ With BioBoston Consulting, you will receive customized CER strategies that align with your device’s classification, evidence, and business goals.
Need Expert Help with Your CER and EU MDR Strategy?
The EU MDR landscape is complex, and building a compliant, evidence-driven Clinical Evaluation Report is a critical part of gaining and maintaining CE Marking.
At BioBoston Consulting, we provide:
- Comprehensive CER development services
- CEP creation and strategic planning
- Systematic literature review and data analysis
- Equivalence assessments and SOTA benchmarking
- PMCF strategy and integration
- Ongoing CER maintenance and updates
Whether you are preparing your first submission or updating an existing CE Marked device, we bring deep regulatory expertise and cross-functional support to help you succeed.
Get Started Today
🔹 Do not leave your EU MDR compliance to chance. Partner with BioBoston Consulting to develop a Clinical Evaluation Report that stands up to scrutiny and supports your device’s success in the European market.
📩 Contact us today to schedule a free consultation and learn how our EU MDR and CER support services can streamline your compliance efforts and accelerate your path to market.