Description:
This Clinical Evaluation Procedure sets how we plan, run, and maintain clinical evaluation to demonstrate conformity with (EU) 2017/745 Article 61 and Annex XIV.

• Confirm compliance with relevant GSPRs (including benefit-risk and side effects).

• Define CEP and CER requirements per Basic UDI-DI.

• Set rules for level of clinical evidence proportional to class, risk, and market history.

• Justify and document equivalence using technical/biological/clinical characteristics.

• Define when clinical investigations are required and when exemptions apply.

• Run systematic literature searches for S&P, SoA, and acceptance criteria.

• Integrate PMS/PMCF and vigilance data into the clinical evidence base.

• Define SSCP requirements and readability validation where applicable.

Your needs:

• Clinical evaluation procedure

• Clinical evaluation procedure for MDR decision-making

• Reduce rework, strengthen clinical evidence defensibility, and speed up review cycles.

This procedure is used when building or updating clinical documentation to support CE marking and lifecycle compliance decisions.

It aligns expectations for clinical evidence. Equivalence means demonstrating no clinically significant differences that could impact safety or performance; it matters because it drives your evidence strategy. SoA defines the current clinical benchmark; it matters because benefits and risks must be assessed against accepted alternatives.

• Define sufficient clinical evidence proportional to device class and intended use.

• Document and justify reliance on equivalence, including access to data.

• Specify when clinical investigations are required for class III/implantables and exceptions.

• Perform systematic searches and appraise data quality and LoE.

• Demonstrate safety, performance, side-effect acceptability, and overall benefit-risk.

• Trigger and document PMCF when gaps or emerging risks are identified.

At Lexqara, we build CEP/CER frameworks, literature search packages, equivalence rationales, SSCP readiness, and PMS/PMCF linkage—supporting clinical documentation, regulatory strategy, and audit preparedness. Resource Center [https://lexqara.com/resource-center] and Clinical Documentation support [https://lexqara.com/services/clinical-documentation]. EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Request a short gap assessment.