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Project-Based Service · High-Value

Clinical Evidence Is
No Longer Optional.
Neither Is Getting It Right.

EU MDR 2017/745 fundamentally changed what clinical evidence your device must have — and most manufacturers underestimate the gap. We draft Clinical Evaluation Plans, CER sections, evidence gap analyses, PMCF plans, and clinical white papers per MEDDEV 2.7/1 Rev 4 and EU MDR Annex XIV.

Class I Clinical Summary
Class IIa Full CER Drafting
Class IIb Active Device CER
Excl. Class III · Implantables
Discuss Your CER Requirements → See What We Draft ↓
Service at a GlanceProject-Based
Clinical Evidence Documentation
Engagement typeFixed-scope project
FrameworkMEDDEV 2.7/1 Rev 4 · Annex XIV
Classification scopeClass I · IIa · IIb (non-impl.)
Turnaround3–6 weeks (scope-dependent)
Review call included✓ Delivery walkthrough
Sign-off responsibilityManufacturer's Qualified Person
Pricing by classification
Class IIIa · project
$3,000–$6,000
Class IIb Active · project
$5,000–$10,000
Discuss Your Requirements →

Scope and fixed price confirmed before work begins.

Why This Matters

EU MDR Changed the Clinical Evidence Standard. Most Manufacturers Have Not Caught Up.

Under the previous MDD framework, many Class IIa and IIb devices could rely on equivalence data and limited literature reviews to obtain CE marking. EU MDR 2017/745 Article 61 and Annex XIV changed that fundamentally.

VerityNodes drafts the clinical evidence documentation your notified body expects to see — structured correctly, referenced properly, and built on 25 years of regulated device manufacturing context.

Regulatory Framework — Clinical Evidence
🇪🇺
EU MDR 2017/745 — Article 61
Defines the clinical evidence requirement for all CE-marked devices. Sets the obligation for Clinical Evaluation and the conditions under which clinical investigations may be waived.
EU MDR Art. 61 · Annex XIV Parts A & B
📋
MEDDEV 2.7/1 Rev 4
The primary guidance document for clinical evaluation methodology. Defines the CEP structure, literature search methodology, equivalence criteria, data appraisal, and CER content requirements.
MEDDEV 2.7/1 Rev 4 · MDCG 2020-5
🔬
Post-Market Clinical Follow-Up
EU MDR Annex XIV Part B requires a PMCF plan for all devices — demonstrating how post-market clinical data will be gathered, analysed, and fed back into the clinical evaluation.
EU MDR Annex XIV Part B · MDCG 2020-7
🇺🇸
FDA — Clinical White Papers
For FDA 510(k) submissions, clinical summary documentation and white papers summarising the available clinical evidence are used to support substantial equivalence arguments and investor communications.
FDA 21 CFR 807.92 · 510(k) Guidance
What We Draft

Six Clinical Evidence Documents —
Structured for Notified Body Acceptance

Each document is drafted to the specific format and content requirements of the relevant regulatory framework — not to a generic template. Scope is confirmed and fixed before work begins.

01 / 06
🗺️

Clinical Evaluation Plan

MEDDEV 2.7/1 Rev 4 §6 · EU MDR Annex XIV Part A
02 / 06
📚

State-of-the-Art Review

MEDDEV 2.7/1 Rev 4 §8 · MDCG 2020-5
03 / 06
🔍

Clinical Evidence Gap Analysis

MEDDEV 2.7/1 Rev 4 §9 · EU MDR Art. 61
04 / 06
📄

CER Sections — Annex XIV Compliant

EU MDR Annex XIV Part A · MEDDEV 2.7/1 Rev 4 §10
05 / 06
📡

Post-Market Clinical Follow-Up Plan

EU MDR Annex XIV Part B · MDCG 2020-7
06 / 06
📊

Clinical White Papers

FDA 21 CFR 807.92 · Investor Documentation
The Methodology

How a Clinical Evaluation Is Structured Under MEDDEV 2.7/1 Rev 4

S1
Scope Definition
Define the device, its intended purpose, the target population, the intended clinical benefit, and the clinical claims being made. This scope governs everything that follows — errors here compound through all subsequent stages.
MEDDEV 2.7/1 Rev 4 §6 · CEP
S2
Literature & Data Identification
Systematic literature search across relevant databases using a documented search strategy. Identification of clinical data on the subject device, equivalent devices, and the state of the art. All data sources documented with inclusion and exclusion criteria.
MEDDEV 2.7/1 Rev 4 §7 · Annex A4
S3
Appraisal & Analysis
Critical appraisal of each data source for suitability and contribution to the clinical evaluation. Analysis of the clinical data pool against the pre-defined acceptance criteria. Equivalence assessment where applicable — clinical, technical, and biological dimensions all assessed and documented.
MEDDEV 2.7/1 Rev 4 §8–§9 · Annex A6
S4
Conclusions & PMCF Plan
Clinical evaluation conclusions addressing safety, performance, benefit-risk balance, and residual risks. PMCF plan defining how post-market clinical data will continue to be collected and how it feeds back into the evaluation cycle. Periodic update schedule confirmed.
MEDDEV 2.7/1 Rev 4 §10 · Annex XIV Part B
How It Works

From Scoping Call to
Submission-Ready Draft

1
Week 1

Scoping & Document Review

Discovery call to scope your device, classification, existing data, and target market. Fixed project price agreed.

Call + review · week 1
2
Week 1–2

CEP Drafting & Approval

We draft the Clinical Evaluation Plan — methodology, search strategy, equivalence criteria, and acceptance criteria. You review and approve the CEP before full CER drafting begins. This prevents rework caused by scope misalignment.

CEP draft → your approval
3
Week 2–5

Literature Review & CER Drafting

Literature identification, appraisal, and analysis per the approved CEP. Full CER sections drafted — state of the art, equivalence assessment, data appraisal tables, clinical evaluation conclusions, and PMCF plan. One revision round included.

3–4 weeks · one revision
4
Week 5–6

Delivery & Walkthrough

Final delivery + walkthrough call
Clinical Evaluation Report — Structure Extract DRAFT FOR REVIEW
1
Device Description & Intended Purpose
DoneDevice identification, classification, and intended purpose — structured per EU MDR Annex II §1
DoneTarget population and clinical indications — aligned with labelling and IFU
2
State of the Art
DoneCurrent standard of care review — 14 literature sources appraised and summarised
DraftBenchmark performance data — comparator device performance reviewed
3
Equivalence Assessment
DraftClinical equivalence — same intended purpose, patient population, and disease state
DraftTechnical equivalence — design, materials, dimensions, and deployment method
GapBiological equivalence — contact material data required from manufacturer
4
PMCF Plan
DraftPMCF rationale and data sources — per EU MDR Annex XIV Part B
DraftPMCF report schedule — annual review cycle confirmed
4
CER Sections
2
Done
5
In Draft
1
Gap — Action
Investment

Fixed-Scope, Fixed-Price.
No Surprises.

Class IClass IIa

CER Package

Full clinical evidence documentation suite for Class I or IIa non-active devices. Covers CEP through to complete CER sections and PMCF plan. Scope confirmed at project start — price fixed before work begins.
$3,000–$6,000
fixed per project · scope-dependent
  • Clinical Evaluation Plan (CEP)
  • State-of-the-art literature review
  • Clinical evidence gap analysis
  • Full CER sections — Annex XIV compliant
  • PMCF plan — Annex XIV Part B
  • Delivery walkthrough call
  • One revision round included
Discuss Your CER →
Class IIb Active

Active Device CER Package

Full clinical evidence documentation for Class IIb active devices — reflecting the more rigorous evidence standard notified bodies apply at this classification level. Includes active device-specific equivalence assessment and IEC 60601 performance parameter context.
$5,000–$10,000
fixed per project · scope-dependent
  • Clinical Evaluation Plan (CEP)
  • Extended state-of-the-art review
  • Active device equivalence assessment
  • Clinical evidence gap analysis
  • Full CER sections — Class IIb standard
  • PMCF plan with active device data sources
  • Delivery walkthrough call
  • One revision round included
Discuss Your CER →
💡

Standalone documents available: Not every manufacturer needs the full CER package. If you already have a CER and only need a PMCF plan, a gap analysis, or a clinical white paper for investor or commercial use, we can scope a standalone engagement. Contact us to discuss — we will only recommend what is genuinely needed.

⚖️

An Important and Honest Statement About This Service

The clinical evidence documentation service is a drafting and intelligence support service — not a regulatory certification, clinical sign-off, or qualified person function. Understanding this distinction matters for how you use what we produce.

✓

What VerityNodes does

Drafts structured clinical evaluation documentation to MEDDEV 2.7/1 Rev 4 format and EU MDR Annex XIV requirements. Produces submission-ready drafts for review by your qualified person or clinical expert.

✕

What VerityNodes does not do

📋

Who reviews and signs off

💡

Why this is the right model

Questions Answered

What Manufacturers Ask Before
Commissioning a CER

EU MDR Art. 61 · MEDDEV 2.7/1 Rev 4 vs old guidance
MEDDEV 2.7/1 Rev 4 §7.3 · Equivalence criteria
MEDDEV 2.7/1 Rev 4 §7 — Evaluator qualifications
Discuss Your Requirements

Tell Us About Your Device and Your Clinical Evidence Position

Complete the form. We respond within one business day to schedule a 30-minute scoping call.

  • Response within one business day
  • Scoping call free — no charge until project confirmed
  • Fixed price agreed before work begins
  • Audit clients: 10% discount on CER package
  • One revision round included in all packages
  • UK-registered — VerityNodes Ltd, England & Wales
Discuss Your Clinical Evidence Requirements
We respond within one business day

Response within one business day. No obligation to proceed.

VerityNodes Ltd · [email protected] · Registered in England and Wales.
 · Privacy · Terms Clinical evidence drafting support — not regulated legal, clinical, or regulatory affairs advice. All CER sign-off remains the manufacturer's responsibility.

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