We support manufacturers with the clinical evidence they need for UKCA/CE marking under MDR and IVDR.
Our team prepares Clinical Evaluation Reports (CERs) for medical devices and Performance Evaluation Reports (PERs) for IVDs, including literature review, evidence appraisal, gap analysis, and clear links to PMCF/PMS activities.
Our Clinical Evaluation Services
Clinical Evaluation Reports (CERs)
CER authoring and updates aligned to MDR Annex XIV—scoping, data appraisal, and clearly documented clinical benefit/risk.
Performance Evaluation Reports (PERs)
PER development under IVDR Annex XIII—performance objectives, data evaluation, and clear performance conclusions.
Literature Review & Evidence Appraisal
Search strategy, screening, data extraction, and critical appraisal of clinical or performance evidence to support CER/PER conclusions.
Clinical Evidence Gap Analysis
Identify gaps in your technical documentation and clinical/performance evidence, with clear actions to close them before notified body submission.
PMCF/PMS Inputs & Safety Narrative
Align your CER/PER with post-market surveillance and PMCF plans, including clinical safety narrative updates and risk/benefit rationale.
Templates & Audit-Ready Documentation
CER/PER templates, evidence tables, checklists and audit-ready documentation aligned to MDR/IVDR expectations.
Why Choose Accurate Assessments for Clinical Evaluation?
- Deep MDR Annex XIV & IVDR Annex XIII experience
- Evidence appraisal with clear traceability
- PMCF/PMS linkage and update planning
- Audit-ready documentation and reviewer-friendly structure
- Responsive, pragmatic support
Ready to strengthen your clinical evidence?
Get in touch to discuss your CER/PER requirements, timelines and the evidence you need to demonstrate clinical benefit and safety.