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Clinical Evaluation Plan

A clinical evaluation plan is a strategic plan that defines the clinical evaluation process required by MEDDEV 2.7/1 rev 4 and EU MDR article 61 and Annex XIV Part A. The clinical evaluation plan acts as planning document for your clinical evaluation and all the activities of Clinical Evaluation are carried out as per the Clinical Evaluation Plan.
Both MEDDEV 2.7/1 rev 4 and MDR 2017/745 Annex XIV part A provides more details on the requirement of the clinical evaluation plan

Indian-mdr-img

Below are the requirements of MDR 2017/745 Annex XIV part A:

  • Identification of GSPR that require relevant clinical data.
  • Specification of the intended purpose.
  • Specification of intended target groups with clear indications and contra-indications.
  • Description of intended clinical benefits to patients.
  • Specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects.
  • An indication and specific parameters used to determine the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device based on the state of the art in medicine.
  • Indication of risk-benefit ratio if any animal or human tissue or pharmaceutical components are present.
  • a clinical development plan indicating a progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF with an indication of milestones and a description of potential acceptance criteria;
  • Identification of clinical data relevant to device and its intended purpose through a systemic scientific literature review
  • Appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device

Below are the MEDDEV 2.7/1 rev 4 requirements-

a) Before and after CE marking

  • Device description.
  • Intended purpose, Target group, an indication and should also cover any design features that pose special performance or safety concerns (e.g. presence of medicinal, human, or animal components), the intended purpose and application of the device (e.g. target treatment group and disease, proposed warnings, contraindications, precautions, and method of application.
  • Claims made by the manufacturer about the clinical performance and clinical safety of the device.
  • Information needed for evaluation of equivalence.
  • Risk data such as hazard identification list, clinical risk identified from risk analysis. Clinical evaluation should address the significance of any clinical risks that remain after design risk mitigation strategies.
  • The current state of the art in the corresponding medical fields such as applicable standard and another guidance document, information on other devices such as benchmark devices or other medical alternatives treating a same medical condition.
  • Type and sources of data used in clinical evaluation.

b) After CE marking

  • Important changes in design, materials, or manufacturing procedures, the information supplied by the manufacturer or other claims or claims of equivalence of existing device is still appropriate.
  • If any specific clinical concerns have newly emerged and need to be addressed.
  • PMS data updated in CER with new clinical data for the device under evaluation or equivalent device, new knowledge about potential hazards, risks, performance, benefits, claims.
  • Need for PMS planning activities.

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