EU MDR Clinical Evaluation & CER Strategy

The CER is not a literature report. It is the regulatory conclusion on whether clinical evidence supports safety, performance, clinical benefit and claims under state-of-the-art medical standards.

Review Your MDR Clinical Evidence Strategy

How NKB Structures Clinical Evaluation

Clinical Evaluation Plan (CEP) aligned to intended purpose, claims and GSPR

State-of-the-art and alternative treatment / benchmark technology context

Systematic literature search protocol and documented appraisal methodology

Identification of device-specific and relevant external clinical data

Assessment of clinical claims against available objective evidence

Equivalence strategy (MDR Article 61(3)) & full data-access considerations

Clinical evidence sufficiency and quantitative gap assessment

Benefit-risk integration and residual risk acceptability

Determination on need for premarket clinical investigations

PMCF strategy targeted directly to residual evidence gaps

Clinical Evaluation Report (CER) authoring & annual lifecycle updates

Summary of Safety & Clinical Performance (SSCP) clinical-content alignment

Questions a Senior Notified Body Reviewer Asks

1Does every material clinical claim have supporting clinical evidence?

2Is the evidence specific enough for the exact intended purpose and patient population?

3Is equivalence actually defensible across technical, biological and clinical characteristics?

4Are unfavourable clinical data and limitations transparently evaluated?

5Does the PMCF plan close a defined evidence gap rather than merely collect generic feedback?

6Do CER conclusions align seamlessly with risk management, labeling and PMS?

Expert Differentiator

Unbroken Traceability from Claim to PMCF

We trace Clinical Claims → Evidence → Benefit-Risk → Residual Uncertainty → PMCF. If a claim cannot be traced to sufficient evidence, the issue must be resolved through claim refinement, new evidence or a defined post-market evidence strategy.

CER Document Deliverables

• Clinical Evaluation Plan (CEP)

• Literature Search Protocol & Full Appraisal Report

• Equivalence Rationale & Technical Comparison

• Clinical Evaluation Report (CER)

• Post-Market Clinical Follow-up (PMCF) Plan

• Summary of Safety & Clinical Performance (SSCP)

Audit-Proof Your CER

Have our clinical evaluation writers and former Notified Body assessors audit your CER before submission.

Request CER Review

Deliver Defensible Clinical Evidence That Withstands Notified Body Audits

Our clinical evaluation teams combine medical writing excellence with rigorous regulatory methodology.

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