Clinical
Evaluation
Reports

Leaders in EU MDR Clinical Evidence

Why Clinical Evaluation Matters

Your Notified Body Reads the CER First. Make It Unarguable.

Under EU MDR 2017/745, the Clinical Evaluation Report is the document that carries your CE mark: it must prove, from systematically gathered clinical evidence, that your device's benefits outweigh its risks against the current state of the art. The bar rose sharply from the MDD era — equivalence is harder to claim, literature reviews must be reproducible, and the CER is a living document tied to your post-market data. We plan, author, and defend clinical evaluations that pass notified body review the first time, so a documentation finding never becomes the thing standing between your device and the European market.

CER update due before your next surveillance audit? The literature review alone takes longer than you think.

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Capabilities

From Clinical Evaluation Plan to Notified Body Acceptance.

We support the full clinical evaluation lifecycle: planning the evaluation, building the evidence base, authoring the report, and defending it through notified body review and every update cycle after.

Clinical Evaluation Plans

CEPs per MDR Annex XIV that define scope, GSPRs, clinical benefits, and acceptance criteria before a single search string is run.
Systematic Literature Review

Protocol-driven, reproducible searches with documented appraisal methodology — the part of the CER notified bodies challenge first.
CER Authoring & Remediation

Full authorship aligned to MDR and MEDDEV 2.7/1 Rev 4, plus gap assessment and rewrite of legacy CERs that no longer clear the bar.
Equivalence & State of the Art

Defensible equivalence justifications under Article 61, and SOTA analyses that set benchmarks your data can actually meet.
PMCF & Post-Market Integration

PMCF plans and reports, PSUR alignment, and SSCP drafting, so the CER stays a living document instead of an audit finding.
Notified Body Responses

Deficiency responses, question-letter strategy, and remediation under active review, run by people who know how assessors read.
Clinical Evaluation Plans

A Strong Evaluation Is Won at the Planning Stage.

MDR Annex XIV requires the clinical evaluation to follow a defined and methodologically sound plan — and notified bodies check the report against it line by line. We build CEPs that specify exactly which General Safety and Performance Requirements need clinical support, what the device's clinical benefits and endpoints are, how the state of the art will be defined, and what acceptance criteria the evidence must meet. A precise plan turns the rest of the evaluation into execution instead of improvisation.

What the Plan Covers

  • CEP development per MDR Annex XIV Part A and MDCG guidance
  • Device description, classification rationale, and intended purpose
  • GSPR mapping: which requirements need clinical evidence
  • Clinical benefits, safety and performance endpoints, and acceptance criteria
  • State-of-the-art definition and benchmark methodology
  • Equivalence-versus-own-data strategy decision
  • Inputs to PMCF planning and the clinical development plan
Systematic Literature Review

Reproducible Searches. Defensible Appraisals.

The literature review is where most CERs fail review: searches that can't be reproduced, appraisal criteria applied inconsistently, and favorable papers weighted over inconvenient ones. We run protocol-driven systematic reviews — defined search strings, documented databases, PRISMA-style screening records, and a written appraisal methodology — so every included and excluded study can be defended when the assessor asks why.

How We Search and Appraise

  • Search protocols with defined strings, date ranges, and rerun instructions
  • PubMed/MEDLINE, Embase, and Cochrane Library coverage
  • Screening documentation with PRISMA-style flow and exclusion logs
  • Structured appraisal: suitability, data contribution, and weighting
  • Data extraction tables for safety and performance outcomes
  • Separate state-of-the-art literature reviews for benchmarks
  • Vigilance and adverse event database searches (MAUDE, EUDAMED, national registries)
CER Authoring & Remediation

A Report Your Assessor Can Follow Without a Single Question.

A CER that passes first time reads like a proof: every claim traces to appraised evidence, the benefit-risk conclusion follows from the data presented, and nothing in the report contradicts the risk management file or the IFU. We author complete CERs aligned to MEDDEV 2.7/1 Rev 4 structure and MDR requirements — or take a legacy CER that no longer clears the bar, gap-assess it against current guidance, and rebuild it before your notified body does the assessment for you.

What We Deliver

  • Full CER authorship per MEDDEV 2.7/1 Rev 4 and MDR Annex XIV
  • Benefit-risk analysis tied to defined acceptance criteria
  • Consistency reconciliation with risk management, IFU, and labeling
  • Gap assessments of existing CERs against MDR and MDCG guidance
  • Remediation and rewrite of legacy MDD-era reports
  • Evaluator credentials and declarations of interest that withstand scrutiny
  • Scheduled update cycles aligned to device class and PSUR timing

Notified body deadline approaching? Get senior eyes on your CER before it goes in.

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Equivalence & State of the Art

Equivalence Under MDR Is a Higher Bar. Clear It — or Change Strategy Early.

The MDR turned equivalence from a shortcut into a commitment: technical, biological, and clinical characteristics must all be demonstrated, and for implantables and Class III devices, Article 61(5) requires a contract giving you ongoing access to the equivalent device's technical documentation. We pressure-test equivalence claims against MDCG 2020-5 before you build a CER on them, and construct state-of-the-art analyses that establish honest benchmarks — because a SOTA section written to flatter your data is the first thing an experienced assessor takes apart.

Analyses We Build

  • Equivalence justifications across technical, biological, and clinical characteristics
  • MDCG 2020-5 conformity checks before the strategy is committed
  • Article 61(5) data-access assessment for implantable and Class III devices
  • State-of-the-art reviews of alternative treatments and competitor devices
  • Safety and performance benchmarks derived from SOTA data
  • Objective acceptance criteria for the benefit-risk determination
  • Fallback strategy when equivalence cannot be sustained: PMCF, clinical investigation, or claim narrowing
PMCF & Post-Market Integration

The CER Is a Living Document. Keep It Alive, or It Becomes a Finding.

Under MDR, clinical evaluation never closes: post-market surveillance feeds the PSUR, PMCF fills the evidence gaps the CER identified, and the whole loop must stay consistent on a schedule set by your device class. We design PMCF activities that answer the residual-risk questions your notified body actually asked, and keep the CER, PSUR, PMCF reports, and SSCP telling one coherent story instead of drifting apart between audits.

Keeping the Loop Closed

  • PMCF plans per MDCG 2020-7, sized to the actual evidence gaps
  • PMCF evaluation reports per MDCG 2020-8
  • Survey, registry, and real-world data study design
  • CER update cycles aligned to PSUR cadence and device class
  • Summary of Safety and Clinical Performance (SSCP) drafting for EUDAMED
  • Vigilance and complaint trend integration into the benefit-risk conclusion
  • Consistency maintenance across CER, PSUR, PMS plan, and risk file
Notified Body Responses

When the Question Letter Arrives, the Clock Is Already Running.

A notified body deficiency letter gives you one good shot at a clean response: answer the question asked, change only what the finding requires, and never introduce a new inconsistency while fixing an old one. We draft responses, remediate the underlying documents under active review, and — when a finding reflects a genuine evidence gap rather than a documentation gap — build the honest bridge plan that keeps your certificate moving instead of arguing a position the data can't hold.

How We Respond

  • Deficiency and nonconformity response drafting
  • Root-cause triage: documentation gap versus evidence gap
  • CER remediation under active conformity assessment
  • Question-letter strategy across review rounds
  • Technical documentation audit and surveillance audit support
  • Pre-submission CER reviews simulating notified body assessment
  • Escalation strategy when sponsor and assessor stop agreeing
Adjacent Capabilities

Beyond the CER.

Two situations sit just outside the standard CER cycle: diagnostics facing the IVDR's performance evaluation requirements, and legacy devices whose MDD-era evidence has to survive MDR recertification.

IVDR Performance Evaluation

For Diagnostics, the CER Has a Sibling — and It's Stricter.

Under IVDR 2017/746, in vitro diagnostics need Performance Evaluation Plans and Reports built on three pillars: scientific validity, analytical performance, and clinical performance. Most IVDs moved up in classification under the IVDR, which means devices that never saw a notified body now face full performance evaluation review. We author PEPs and PERs to Annex XIII, and run the literature and performance-data work behind them.

Included Capabilities

  • Performance Evaluation Plans and Reports per IVDR Annex XIII
  • Scientific validity reports from systematic literature review
  • Analytical and clinical performance evidence compilation
  • Classification rationale under IVDR Rule 1–7 framework
  • Post-Market Performance Follow-up (PMPF) plans and reports
  • Remediation of IVDD-era documentation for IVDR review
Legacy Device Transitions

The Evidence That Earned Your CE Mark May Not Keep It.

Devices certified under the MDD face a harder question at MDR recertification: is the existing clinical evidence still sufficient under MDCG 2020-6, or has the state of the art moved past it? We gap-assess legacy clinical evidence honestly, tell you which claims survive and which need PMCF or new data, and manage the documentation uplift on a timeline that respects your certificate expiry — not just the ideal project plan.

Included Capabilities

  • MDD-to-MDR clinical evidence gap assessments per MDCG 2020-6
  • Sufficient-clinical-evidence determinations for legacy devices
  • Well-established technology (WET) justifications where applicable
  • Technical documentation uplift planning against certificate expiry
  • Up-classified device strategy (Class I reusable, software, substances)
  • Claim and indication narrowing to match the surviving evidence
Who You're Working With

Written by People Who Know How It Will Be Reviewed.

CER work is cross-functional by nature: clinical judgment, systematic review methodology, risk management fluency, and regulatory writing discipline in one team. Ours combines medical writers, clinicians, and former notified body and industry reviewers — so the report is written the way it will be assessed.

Notified Body Perspective

Consultants who have reviewed technical documentation and clinical evaluations on the assessment side. They know which sections get read first, and which findings get written most often.

Clinicians and Medical Writers Together

Physician-level clinical judgment on benefit-risk paired with writers who produce clean, traceable, audit-ready documents. Neither alone survives a hard review; together they pass it.

Whole-File Consistency

We work across the technical documentation, not just the CER — risk management file, PMS system, IFU, and labeling — because assessors find their deficiencies in the seams between documents.

Device and Diagnostic Breadth

Implantables, surgical instruments, software as a medical device, combination products, and IVDs — from Class I reusable instruments to Class III implants and Class D diagnostics.

Work With Us

Your Next CER Cycle Starts Now.

Tell us where the device stands — first CE mark, MDR transition, scheduled update, or an open deficiency letter. We'll match you with a senior clinical evaluation lead and respond within one business day. All inquiries are strictly confidential.

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Insights & News

Thought Leadership on Clinical Evidence.

Our team's perspectives on clinical evaluation, MDR evidence strategy, and what notified body assessors actually flag: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.

Coming Soon

Equivalence Under MDR: When to Abandon It

The Article 61 tests most devices fail, and the strategies that work when they do.

Coming Soon

How Notified Bodies Actually Read Your CER

The sections assessors check first, and the findings they write most often.

Coming Soon

PMCF That Answers the Question Asked

Designing post-market follow-up around real evidence gaps, not checkbox surveys.