Clinical Evaluation Plans under MDR

Building A Strategy You Can Defend

Navigating clinical evaluation under EU MDR can feel complex - specially when you’re working with legacy data, evolving expectations, and increasing scrutiny from Notified Bodies.

For many manufacturers, the Clinical Evaluation Plan (CEP) is treated as a formality - a document to complete before moving on to the “real work.”

Under MDR, that approach creates risk, because the CEP is no longer just a starting point. It’s where your entire clinical strategy begins to take shape - and where gaps, inconsistencies, or assumptions quickly become visible.

Why the CEP matters more than ever 

Under MDR, clinical evaluation is not a one-off exercise. It’s a continuous, lifecycle process that must demonstrate that your device is safe, performs as intended, and delivers a positive benefit–risk profile.

This expectation is clearly set out in the regulation and reinforced through guidance. Clinical evidence must be sufficient, justified, and continuously updated to support conformity with the General Safety and Performance Requirements (GSPRs).

At the same time, MEDDEV 2.7/1 Rev. 4 remains widely recognised as state of the art for how clinical evaluation should be performed - particularly in areas like literature appraisal, data analysis, and scientific validity.

And importantly, MDCG 2020-13 shows how Notified Bodies will assess your work in practice - through a structured, detailed review of your clinical evidence and its conclusions.

Where CEPs typically go wrong

Most CEPs don’t fail because of missing sections - they struggle because the clinical reasoning isn’t clear or robust enough.

Common issues include:

• The intended purpose, indications, and claims aren’t aligned across documents 

• Clinical benefits are described, but not linked to measurable outcomes 

• The level of clinical evidence isn’t clearly justified 

• Literature searches are narrow or difficult to reproduce 

• Equivalence is assumed rather than demonstrated 

• PMS and PMCF are treated as separate activities - not part of the evidence strategy. 

A simple test is often revealing.

If your CEP could apply to multiple devices with only minor edits, it’s probably not specific enough.

What Regulators and Notified Bodies are really looking for

Across MDR, MDCG guidance, and established best practice, there’s a consistent expectation:

Your CEP should clearly explain how you will demonstrate and maintain clinical evidence - not just what sections you’ve included.

In practical terms, that means:

1. Start with the device

Define the intended purpose, target population, indications, contraindications, and expected clinical benefits clearly.

2. Justify the level of clinical evidence

Explain what level of evidence is needed - and why it’s appropriate for your device, risk class, and intended use.

3. Identify and critically appraise all relevant data

This includes pre-market and post-market sources:

• literature 

• clinical investigations 

• PMS and PMCF data 

• complaints and vigilance (where relevant) 

  
  

And importantly - this should follow a methodologically sound, reproducible approach, as outlined in MEDDEV 2.7/1 Rev. 4.

4. Connect benefit–risk to the state of the art

Your evaluation should reflect current clinical practice and available alternatives - not just your device in isolation.

5. Plan for gaps and ongoing updates

No dataset is perfect. What matters is whether gaps are identified, understood, and addressed through a clear strategy.

Building a stronger CEP: a practical approach 

Step 1: Define the device with clarity and consistency

Your CEP can only be as strong as the foundation it’s built on.

Make sure your:

• device description 

• intended purpose 

• patient population 

• indications and contraindications 

  …are consistent across your technical documentation.

Even small inconsistencies can undermine your entire clinical argument during review.

Step 2: Translate claims into evidence

Under MDR, claims must be supported - not assumed.

Ask:

• What clinical benefits are we claiming? 

• How will these be measured? 

• What evidence is needed to demonstrate them? 

  
  

This turns your CEP into a clear, evidence-driven plan, not just a descriptive document.

Step 3: Define and justify your evidence strategy

MDR requires you to specify and justify the level of clinical evidence needed.

This should consider:

• device risk class 

• novelty 

• intended purpose 

• available data 

• remaining uncertainty 

  
  

For legacy devices, this is particularly important - because historical data may no longer be sufficient on its own.

Step 4: Build a transparent, reproducible literature strategy

A literature review should not be a search for supportive evidence.

It should be a structured, unbiased process that identifies:

• favourable and unfavourable data 

• safety concerns 

• alternative treatments 

• state of the art.

  
  

And it should be documented clearly enough that it can be reviewed and reproduced.

Step 5: Be realistic about equivalence

Equivalence is still possible under MDR - but it requires robust justification and access to data.

In practice, this means:

• demonstrating technical, biological, and clinical equivalence 

• having sufficient access to underlying data 

• understanding when equivalence is no longer viable. 

  
  

For many manufacturers, this is a critical decision point.

Step 6: Address gaps openly and strategically

Every clinical evaluation includes uncertainty.

The key question is not whether gaps exist - but whether they are:

• clearly identified 

• appropriately assessed 

• managed through a credible plan. 

  
  

This might involve:

• PMCF activities 

• additional data collection 

• refining claims or intended purpose.

Step 7: Integrate PMS, PMCF, and lifecycle updates

Under MDR, clinical evaluation doesn’t stop at certification.

Your CEP should clearly explain:

• how PMS and PMCF feed into the CER 

• how new data will be evaluated 

• when updates will be triggered.

  
  

This is where many strategies fall short - and where Notified Bodies will focus their attention.

What a well-structured CEP achieves

A strong CEP doesn’t feel longer - ait feels clearer.

It allows a reviewer to quickly understand:

• What your device is and what it claims 

• What evidence is required 

• What evidence exists - and how strong it is 

• Where the gaps are - and how they’ll be addressed 

• How the strategy will evolve over time.

How our team can support you

You don’t need to start from scratch. Most manufacturers we work with are building on:

• legacy documentation 

• existing data 

• tight timelines. 

Our role is to bring structure and clarity to that process.

We support:

• CEP and CER gap assessments 

• Clinical strategy development 

• Claim-to-evidence mapping 

• Literature review design and appraisal 

• Equivalence strategy review 

• PMS and PMCF integration 

• Preparation of reviewer-ready documentation. 

The goal is simple: 

To move from a document that exists… to a strategy you can confidently defend.

Free 30-Minute Regulatory Strategy Call

Get clear, expert insight into your medical device regulatory strategy in a no-strings-attached 30-minute call with one of our experts. Whether you’re preparing for EU MDR, UKCA, or global submission, this session will quickly highlight where you stand - and where you can strengthen your approach.

In this call, you will:

• Uncover weaknesses in your clinical and regulatory documentation

• Spot risks that could delay approval or raise questions during review

• Get clarity on classification, routes to market, and compliance strategy

• Understand how ready you are for audit or Notified Body scrutiny

• Leave with practical, prioritised next steps

  
  

No pressure. Just straightforward, high-value guidance to help you move faster and with confidence.