At Simplimedica Ltd, we provide comprehensive Clinical Evaluation and Performance Evaluation services to ensure your Medical Device or In Vitro Diagnostic (IVD) meets the evidence requirements of the EU MDR, EU IVDR, and UKCA regulatory frameworks. Our team combines regulatory expertise, clinical research capability, and deep technical understanding to deliver clear, compliant, and audit-ready clinical evidence.
Under the EU MDR (2017/745) and the UKCA requirements, every medical device must demonstrate clinical safety and performance through a structured Clinical Evaluation. Our Clinical Evaluation services include:
We develop a robust Clinical Evaluation Plan outlining the clinical strategy, data sources, safety endpoints, and procedures required to meet MDR and UKCA expectations.
Our systematic literature reviews follow recognised methodologies and are fully traceable, reproducible, and aligned with MEDDEV 2.7/1 Rev.4 and MDR Annex XIV.
We define the clinical context, alternatives, and benchmark performance criteria to demonstrate your device’s position within current medical practice.
We critically evaluate all clinical data — published, unpublished, post-market, and internal — to produce a balanced, unbiased assessment of safety, performance, and clinical benefits.
We deliver a fully compliant CER ready for submission to your Notified Body or Approved Body, including evidence gaps, risk–benefit analysis, and PMS/PMCF integration.
We develop and execute PMCF Plans and Reports to ensure ongoing compliance and lifecycle evidence generation.
IVDR has significantly increased the evidence burden for IVD manufacturers. Simplimedica supports you through the full Performance Evaluation lifecycle, from analytical validation to scientific validity and clinical performance studies.
Our Performance Evaluation services include:
We design a complete PEP that aligns scientific validity, analytical performance, and clinical performance requirements (Annex XIII IVDR).
We gather and appraise all evidence demonstrating the relationship between the analyte and the clinical condition, supported by systematic literature review.
We define and manage analytical validation studies, including accuracy, precision, sensitivity, specificity, LoD, LoQ, reproducibility, and interference testing.
Where required, we plan and oversee clinical performance studies or evaluate existing clinical data to demonstrate the test’s clinical sensitivity, specificity, and diagnostic accuracy.
We produce a comprehensive, audit-ready PER, including scientific validity, analytical data, clinical performance results, and benefit–risk evaluation.
We develop PMPF plans and reports that ensure continuous evidence generation across the IVD lifecycle.
Whether you need a single CER/PER, a complete MDR/IVDR evidence package, or ongoing PMS/PMCF/PMPF support, Simplimedica provides the expertise and clarity you need to achieve compliance efficiently.
Get in touch today to discuss your Clinical Evaluation or Performance Evaluation requirements.
End-to-end support from CEP/PEP planning through to CER/PER submission.
Experienced regulatory professionals specialising in MDR and IVDR evidence requirements.
High-quality, audit-ready documentation trusted by Notified Bodies and regulators.
Expertise across Class I–III devices and Class A–D IVDs, including innovative and high-risk technology.
Integrated regulatory, clinical, and quality expertise ensuring smooth pathway to approval.
