Generate a CER draft aligned to MDR/IVDR section headings

Faster, more consistent drafts

Why use a CER generator

Drafting a CER from scratch is time-consuming and often inconsistent across teams. The Free CER Generator provides a structured starting draft and repeatable prompts that: reduce formatting decisions, ensure coverage of regulator-expected sections, and produce reproducible search strategies and evidence-matrix rows. Use the output to accelerate internal review and to focus expert time on appraisal and conclusions.

• Reduce administrative drafting time so senior reviewers can focus on appraisal and clinical judgement
• Standardize CER structure across devices and product lines
• Produce reproducible literature-search strings and inclusion/exclusion criteria for auditability

From factsheet to draft

How the generator helps your CER workflow

The generator is prompt-driven: you provide a device factsheet and study notes or abstracts, then select prompts to create the CER introduction, clinical context, evidence-matrix rows, critical appraisals, and a benefit–risk conclusion. The tool outputs editable paragraphs, tables-ready summaries, and a reviewer checklist to streamline QMS sign-off.

Ready-to-use prompt clusters

Prompt library — practical prompts you can run

Use these proven prompt clusters to produce specific CER sections and reproducible artifacts. Each prompt is written to accept your device factsheet or study abstracts as input.

• Device summary → CER introduction: "From the following device factsheet (intended use, indications, main materials, mechanism of action, device codes), write a concise CER Introduction and device description suitable for the technical file."
• Intended use & clinical context: "Draft a 200–350 word section that explains the clinical problem, target population, standard of care, and where this device fits in therapy pathways."
• Literature search strategy: "Generate reproducible search strings and inclusion/exclusion criteria for academic databases to capture clinical evidence relevant to this device (keywords, MeSH suggestions, date ranges, study types)."
• Evidence matrix population: "Convert a set of study abstracts into table rows: study citation, design, population, outcomes, relevance to device, quality rating, applicability notes."
• Critical appraisal: "Produce a study-by-study critical appraisal summary using risk-of-bias checkpoints and applicability to the device’s specific claims."
• Benefit–risk conclusion: "Draft a balanced benefit–risk conclusion that references the evidence matrix and highlights gaps, uncertainties, and proposed mitigations or post-market activities."
• Post-market surveillance & gap plan: "Outline a focused post-market surveillance plan and suggested data collection to address identified evidence gaps after market entry."
• Reviewer checklist & sign-off items: "Create a checklist of items a qualified regulatory reviewer must confirm before CER sign-off (literature completeness, applicability, conflicts of interest, documented search methods)."

Turn literature into structured evidence

Evidence matrix & critical appraisal

The generator helps you transform search results into reproducible evidence-matrix rows and appraisal summaries. Prompts guide reviewers through standard risk-of-bias checkpoints and help document applicability of each study against the device’s claims.

• Standard fields: citation, design, population, outcomes, relevance, quality rating, applicability notes
• Critical-appraisal prompts surface limitations, confounding factors, and generalisability concerns
• Appraisal outputs are written for inclusion in the CER and for use by clinical reviewers

Support for QMS and sign-off

Reviewer checklist & regulatory readiness

Use the included reviewer checklist to document the items required for qualified sign-off. The checklist is editable and intended to be adapted to your organization’s QMS and reviewer roles.

• Checklist items include literature completeness, documented search methods, declaration of conflicts, and applicability confirmations
• Templates for conclusion sign-off and documented limitations help create an auditable record
• Outputs are explicitly labeled as draft content requiring qualified expert review

Editable content for your technical file

Export and editorial workflow

Generated text is provided as editable paragraphs and table-ready summaries that can be copied into Word or a PDF workflow. The generator focuses on producing clean, editable text and structured outputs to fit typical technical-file and QMS processes.

• Copy/paste-ready paragraphs and table rows
• No proprietary file locks — integrate into your document control process
• Guidance included on required verification steps before filing

Targeted for regulatory and clinical teams

Who this helps

The Free CER Generator is designed for regulatory affairs managers, quality and clinical teams, regulatory consultants, and startup founders preparing clinical documentation. It accelerates drafting while leaving clinical judgments and formal sign-off to qualified experts.

• Regulatory affairs managers preparing technical files and CERs
• Clinical affairs teams needing structured evidence summaries
• Quality and RA/QMS teams who require consistent templates and checklists
• Consultants and contract authors who need a reproducible drafting workflow

Where to apply the outputs

Source ecosystem and compliance context

Outputs are designed to align with commonly referenced CER formats and regulatory expectations (for example, MDR/IVDR-style sectioning), and to work alongside literature from academic databases, trial registries, peer-reviewed journals, and your internal post-market surveillance records. Use generated search strings in primary databases and import results into the evidence matrix for appraisal and documentation.

• Apply reproducible search strings to PubMed, Embase, and trial registries
• Combine generated evidence rows with internal PMS and device master records
• Adapt reviewer checklists to your QMS and documented procedures