Clinical evaluation · CER
Clinical evaluation software for the CEP, literature and CER
Clinical evaluation software supports the process required by MDR Article 61 and Annex XIV Part A: planning the clinical evaluation, identifying and appraising clinical data, analysing whether the data are sufficient to confirm safety, performance and the benefit-risk ratio, and documenting the result in a clinical evaluation report (CER). MDRpilot holds the clinical evaluation plan, runs literature searches in PubMed and Europe PMC, records PRISMA-style screening counts and equivalence data, keeps a clinical gap matrix and produces a CER draft that goes through review and approval.
Who it is for
- Clinical and regulatory specialists writing CEPs and CERs
- Manufacturers relying on literature and equivalence
- Teams updating CERs with PMS and PMCF data
Key capabilities
Clinical evaluation plan
Structured CEP built from the product's intended purpose, claims and GSPRs.
Literature search
Search PubMed and Europe PMC, record the query and keep PRISMA-style counts for identified, screened, excluded and included records.
Equivalence table
Technical, biological and clinical characteristics side by side with your justification.
Clinical gap matrix
Shows which claims and GSPRs lack sufficient clinical data, which feeds the PMCF plan.
Clinical evidence from uploads
Uploaded files that look clinical are proposed as clinical evidence and, once confirmed, are included in the CER context.
Review workflow
Submit for review, approve or reject, with history.
The clinical evaluation stages
| Stage | Output |
|---|---|
| Plan | Clinical evaluation plan (Annex XIV Part A, Section 1a): GSPRs needing clinical data, intended purpose, target groups, benefits, outcome parameters, method |
| Identify | Literature search protocol and results, own clinical investigation data, PMS and PMCF data |
| Appraise | Relevance and quality of each data set |
| Analyse | Whether the data are sufficient for safety, performance and benefit-risk |
| Report | Clinical evaluation report, updated with post-market data |
Equivalence under MDR is harder than under MDD
Claiming equivalence requires technical, biological and clinical characteristics to be similar enough that there is no clinically significant difference in safety and performance (Annex XIV Part A, Section 3; MDCG 2020-5). For implantable and Class III devices, Article 61(5) also requires a contract that gives ongoing access to the equivalent device's technical documentation, with limited exceptions. MDRpilot records each characteristic and its comparison, so the justification is explicit.
How the workflow runs
- 1
Plan
Write the CEP from the product record.
- 2
Search
Run and document the literature search.
- 3
Appraise
Screen and appraise the records; document equivalence if used.
- 4
Report
Draft and approve the CER.
- 5
Update
Feed PMS and PMCF findings into the next CER revision.
Connected to the rest of the file
MDRpilot is not a stand-alone document generator. Requirements, evidence and documents share one product record.
Each step reads from the same product record. A test report linked to a GSPR row can verify a risk control, a change to the device class flags the documents that depend on it, and the audit readiness view counts what is still open across all of them.
Limitations
- MDRpilot does not decide whether clinical evidence is sufficient; that is a judgement for qualified evaluators and the notified body.
- Search coverage depends on the databases queried; you may need additional sources such as Embase or registries.
- Full-text appraisal must be done by people who have read the articles.
- Clinical evaluation authors must have the qualifications described in MDCG guidance; MDRpilot does not provide them.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.
Frequently asked questions
Can MDRpilot help with clinical evaluation?
Yes. It structures the CEP, runs literature searches in PubMed and Europe PMC, records screening counts and equivalence, keeps a clinical gap matrix and drafts the CER for your review.
Does MDRpilot write the CER for me?
It drafts the CER from your plan, data and confirmed evidence. The evaluator must review, complete and sign it.
What is the difference between a CEP and a CER?
The CEP plans the clinical evaluation before data are collected. The CER documents the data, their appraisal and the conclusion on safety, performance and benefit-risk.
How often must the CER be updated?
Article 61(11) requires the clinical evaluation to be updated throughout the lifecycle with PMCF data. For Class III and implantable devices, the PMCF evaluation report and, if indicated, the SSCP must be updated at least annually; the CER update cycle is usually aligned with that.
Does MDRpilot support MDCG 2020-13?
The CER structure follows the topics a notified body checks using the MDCG 2020-13 assessment report template, so reviewers find the information they expect.
Related workflows
- PMS and PMCF software that feeds back into risk and clinical evaluationPost-market surveillance under MDR Articles 83–86: PMS plan, PMCF plan and survey, PSUR or PMS report by device class, linked to complaints, CAPA and risk.Read more
- GSPR compliance with evidence you can traceMap every MDR Annex I General Safety and Performance Requirement to applicability, standards and evidence, and see which GSPR rows are still unsupported.Read more
- ISO 14971 risk management software connected to your evidenceMaintain an ISO 14971:2019 risk management file per device: plan, hazard analysis, risk controls, verification of controls and benefit-risk, linked to GSPR and PMS.Read more
- Technical file software for MDR devicesBuild and maintain an MDR technical file per device: Annex II and III structure, section status, AI-assisted drafts, linked evidence and DOCX, PDF or ZIP export.Read more
- Audit readiness for MDR and ISO 13485 auditsPrepare for notified body and internal audits with a readiness score, a list of missing actions across technical file, QMS and CAPA, and an audit simulator.Read more
Guides and resources
- Clinical Evaluation Report (CER) GuideHow to plan and write an MDR clinical evaluation report: CEP contents, data sources, literature search, appraisal, equivalence, sufficiency, PMCF and updates.Read more
- PMS and PMCF ExplainedPost-market surveillance and post-market clinical follow-up under the EU MDR: PMS system, PMS plan, PMS report and PSUR, PMCF plan and report, vigilance and trend reporting.Read more
- EU MDR Technical Documentation: Complete GuideWhat EU MDR technical documentation is, who reviews it, how long to keep it, how it connects to the QMS and how to keep it current over the device lifecycle.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- MDCG 2020-13 Clinical evaluation assessment report template — Medical Device Coordination Group. Listed under clinical investigation and evaluation.
- MDCG 2020-5 Clinical evaluation — equivalence — Medical Device Coordination Group. Listed under clinical investigation and evaluation.
- MDCG 2020-6 Sufficient clinical evidence for legacy devices — Medical Device Coordination Group. Listed under clinical investigation and evaluation.
- Guidance: MDCG endorsed documents and other guidance — European Commission.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
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