Clinical Evaluation Report for Medical Devices: 2026 Guide

Quick Reference

• CER = Core regulatory requirement for ALL medical devices under EU MDR
• MEDDEV 2.7/1 Rev. 4 = Your bible for CER methodology
• Class IIb/III CERs typically cost €150k-1M+ and take 8-24 months
• 50% of MDR applications face CER-related challenges from Notified Bodies
• Your CER is a living document requiring continuous PMCF updates

Typical CER Cost & Duration by Device Class

What Is a Clinical Evaluation Report (CER)?

A Clinical Evaluation Report (CER) is a document that proves your medical device:

• Is safe
• Works as intended
• Provides more benefit than harm

Under the EU Medical Device Regulation (MDR), every medical device must have a Clinical Evaluation Report MDR as part of its technical documentation. Without a valid CER, your device cannot legally stay on the EU market.

In simple terms:

What is the purpose of Clinical Evaluation Report?

A Clinical Evaluation Report demonstrates that a medical device:

• Is clinically safe
• Performs as intended
• Provides measurable patient benefit
• Has acceptable and controlled risks

Under the Clinical Evaluation Report MDR requirements, the CER is no longer a supporting document. It is a core regulatory file reviewed in detail by Regulatory reviewers.

You are no longer just summarising data. You are building the clinical justification for market access.

Why MDR Has Changed CER Writing Permanently

MDR introduced a deeper level of verification than MDD (old Medical Device Directive) ever required.
In practice, this we must adjust to several MDR Expectations:

• Strong clinical data: Literature must be robust and relevant
• Clear risk–benefit: Clinical safety must be measurable
• Claim verification: Every claim needs traceable proof
• Continuous updating: CER is a living document
• PMCF integration: Real-world data must be included

Regulatory reviewers now assess:

1. Your methodology
2. Your scientific reasoning
3. Your clinical judgement
4. Your data traceability

Top MDR Review Challenges Reported by Manufacturers (2024–2025)

Based on data from MedTech Europe and Notified Body reports, here are the most common CER-related challenges manufacturers face during MDR reviews:

Source: MedTech Europe 2024 Regulatory Survey & BSI/Team-NB reports

CER vs Other Clinical Documents

Many regulatory gaps come from mixing up document roles:

• CER: Clinical justification of safety and performance
• PMCF: Post-market real-world evidence
• Clinical Investigation: Generates original clinical data
• Risk Management File: Identifies and controls hazards
• SSCP: Public-facing clinical summary

Your CER connects all clinical sources into one regulatory narrative.

How CER Components Build on Each Other

Each component must logically support the next. A weak foundation at any level undermines the entire clinical argument.

Clinical Evaluation Report MDR Rules You Must Apply

Your CER must align with:

• EU MDR 2017/745 – Annex XIV
• MEDDEV 2.7/1 Rev. 4
• Relevant MDCG guidance
• ISO 14155 (when investigations exist)

Regulatory Source vs What It Requires in CER

These Clinical Evaluation Report guidelines control:

• Data quality thresholds
• Evidence grading
• Equivalence justification
• PMCF integration
• Frequency of updates

Failure to follow these lead to Notified Body nonconformities

Standard CER Structure (What Works in Real Reviews)

On paper, most Clinical Evaluation Reports follow the same formal structure. But in real MDR reviews, structure alone is not what decides success. What truly matters is whether your CER tells a coherent clinical story that a regulatory reviewer can follow without effort.

I have seen perfectly "structured" CERs fail because the logic between sections was weak. I have also seen less formal-looking CERs pass because the clinical reasoning was clear, consistent, and well supported by evidence.

Yes, you still need the classic elements: device description, intended use, clinical background, state of the art, clinical claims, literature review, safety and performance analysis, risk–benefit evaluation, conclusions, and PMCF integration. But what actually matters is this:

Your CER must read like a clinical justification, not a compliance exercise.

Each section should build naturally into the next. Your intended purpose must clearly lead into your claims. Your claims must clearly lead into your literature strategy. Your literature must clearly support your safety and performance analysis. And your risk–benefit conclusion must feel inevitable by the time the reviewer reaches the end.

If the reviewer feels they are being "walked" through the logic, you are on the right track.

How I Approach CER Writing in Practice

When I work on a CER, I never start with templates. I start with two questions:

1. What exactly is this device claiming to do?
2. What clinical proof already exists that it really does that safely?

Everything else flows from those answers.

Only after I understand the device and its actual clinical promise do I look the structure. Otherwise, the report becomes a mechanical exercise that looks correct but feels hollow during review.

This is especially important under MDR, where the CER is no longer just a summary of studies. It is the main clinical defence of the device.

How to Write a Clinical Evaluation Report Without Losing the Plot

Let's talk honestly about how CER writing really works in 2026, not just how it looks in guidance documents.

You always start with the device. Not with literature. Not with MEDDEV. Not with templates. If the intended purpose is vague, nothing else will hold.

Once the device and claims are clear, the literature search becomes meaningful. You are no longer "searching broadly". You are looking for very specific clinical answers. Does this intervention work? How well? In what patient group? Compared to what?

This is also where many writers struggle, because poorly written claims force them into weak literature mapping later. If your claim is vague, your evidence will always feel stretched.

When you move into safety and performance analysis, you are no longer acting only as a writer. You are applying clinical judgement. You are weighing complications, uncertainty, and real world risk. This is why MDR reviewers look so closely at reasoning, not just references.

And finally, when you write your conclusions, the most important test is this:

If a reviewer skipped to your conclusion, would they feel confident that the earlier sections truly support it?

If the answer is even slightly "maybe", the conclusion is too weak.

Why Risk–Benefit Is Now the Hardest Part of the CER

Under MDD, risk–benefit sections were often short and generic. Under MDR, this is no longer possible.

In many MDR reviews, this is the section where most nonconformities appear.

Why? Because you are now expected to show, clearly and transparently:

• What the real risks are
• How often they occur
• How severe they are
• And exactly why the benefits still outweigh them

This forces alignment between:

• The CER
• The Risk Management File
• The PMS system
• The PMCF plan

If even one of those documents tells a different story, the reviewer will find it.

From experience, when a CER fails, it usually does not fail because of missing references. It fails because the risk–benefit logic does not fully close.

Example of MDR-Strength Risk–Benefit Logic

Notice how each row connects frequency, severity, and benefit with specific evidence sources. This is the level of rigor MDR reviewers expect.

How Long a Real MDR CER Actually Takes

Official timelines often sound optimistic. Reality is usually different.

In clean projects with good inputs, a Class IIa CER might be completed in a month or two. But most real projects involve:

• Incomplete literature
• Misaligned claims
• Gaps in PMS data
• Weak PMCF planning
• Or outdated state-of-the-art sections

When these issues appear, the CER becomes a corrective project, not just a writing task. This is why Class IIb and III CERs often stretch into several months.

The key lesson from practice is simple:

A CER is rarely late because of writing. It is late because the clinical story is not ready.

The Most Common CER Failures I See in MDR Reviews

After reviewing many failed CERs, clear patterns appear.

The most common problems are not technical. They are conceptual.

Most Common Root Causes of CER Nonconformities

Based on regulatory review experience across 100+ CER assessments. Notice how 75% of failures stem from just three root causes.

I repeatedly see CERs where:

• Claims are copied from marketing and are not clinically defensible
• Equivalence is assumed but not proven
• Literature is summarised but not critically appraised
• PMCF is mentioned but not integrated into the conclusions
• The state of the art section is outdated or superficial

How CER Updating Feels Under MDR

Many people still underestimate what "living document" really means.

In practice, MDR turns your CER into a permanent clinical monitoring file. Every serious complaint, trend, or PMCF outcome eventually flows back into the CER.

For lower-risk devices, updates may be less frequent. For higher-risk classes, the CER becomes a continuous process rather than a periodic task.

This changes how medical writers work. You are no longer just delivering a document. You are supporting a long-term clinical evidence strategy.

Who Really Carries Responsibility for the CER

Even if you write the CER as a consultant or medical writer, the legal responsibility always stays with the manufacturer. But in reality, your judgement as the writer carries enormous practical weight.

Your clinical interpretations influence:

• Certification decisions
• Market access
• Patient safety
• And sometimes the survival of the product line

This is why MDR has quietly elevated the role of the medical writer. You are no longer just a technical author. You are part of the device's clinical defence.

The Reality of AI in CER Writing Today

AI is now part of almost every CER project in some form. It speeds up literature screening, drafting, and data extraction. Used correctly, it saves weeks of work.

But the line is very clear:

AI can organise information. It cannot provide clinical judgement.

Every MDR CER still depends on:

• Human interpretation
• Human responsibility
• Human accountability

Regulatory reviewers know this. That is why purely AI-generated CERs fail quickly once reviewed in depth.

How Qmedify Helps Medical Writers Build Better CERs Faster

Writing MDR-compliant CERs is complex, time-consuming work. Medical writers face constant pressure to deliver faster while maintaining quality and regulatory defensibility.

Qmedify is built specifically to support medical writers through the most challenging parts of CER development:

Intelligent Literature Analysis

Instead of manually screening hundreds of papers, Qmedify helps you rapidly identify relevant clinical evidence, extract key data points, and grade evidence quality according to MEDDEV 2.7/1 standards. This cuts literature review time by 60-70% while improving consistency.

Claims-to-Evidence Mapping

One of the most common CER failures is weak mapping between clinical claims and supporting evidence. Qmedify provides structured workflows to ensure every claim is traceable to specific, graded evidence sources—eliminating one of the top causes of Notified Body nonconformities.

Risk–Benefit Documentation

Qmedify guides you through building clear, quantified risk–benefit analyses with proper frequency/severity documentation. The platform ensures your risk–benefit logic aligns with your Risk Management File and PMCF data—the integration that MDR reviewers scrutinize most carefully.

MDR Compliance Validation

Before submission, Qmedify checks your CER against MDR requirements, MEDDEV guidance, and common Notified Body objections. You catch gaps early, before they become expensive delays.

PMCF Integration Workflows

Qmedify makes it practical to maintain your CER as a living document. As PMCF data comes in, the platform helps you assess clinical significance and update your CER conclusions systematically, not as a crisis response, but as routine maintenance.

If you're facing a complex CER project, tight deadlines, or recurring Notified Body challenges, schedule a consultation to see how Qmedify can support your work.

FAQ: Clinical Evaluation Report Questions

CER Readiness Self-Assessment Checklist

Before submitting your CER for Notified Body review, use this checklist to identify gaps and reduce the risk of nonconformities:

Any "Critical" or "High" risk item marked incomplete should delay submission until addressed. This checklist could be used during CER development.

The Bottom Line for Medical Device Manufacturers

MDR did not just tighten the rules. It changed the nature of CER writing itself.

A modern CER is no longer a literature summary, a formal requirement, or a one time document. It is now a living clinical argument, a regulatory defence, and a continuous safety justification.

If your CER tells a clear, honest, well-evidenced clinical story, MDR becomes manageable. If it does not, no amount of formatting or templates will save it.

Invest in getting it right the first time. Budget realistically (both time and money). Engage clinical and regulatory experts early. Document everything meticulously. And remember: a strong CER doesn't just get you through regulatory approval, it demonstrates to customers, investors, and healthcare providers that your device is backed by solid clinical evidence.