Clinical and Performance Evaluation

In the medical device sector, clinical evaluation and performance validation are highly relevant and essential steps to obtain CE marking for any medical device, demonstrating its clinical efficacy. This is emphasized by MDCG Guidelines and the European Regulations on Medical Devices (MDR 2017/745) and In Vitro Diagnostics (IVDR 2017/746).

Clinical evaluation and performance validation rely on two key components: pre-clinical evaluation, including performance validation, and clinical evaluation, encompassing literature review and clinical investigation. Both require specialized expertise and a multidisciplinary team, including clinical personnel, to ensure scientific rigor, objectivity, and reliability of conclusions.

Maytal can support you with:

• Pre-clinical evaluation and performance validation: Assisting and guiding manufacturer personnel in collecting and analysing data to demonstrate scientific validity, performance (including analytical performance for IVDs), and clinical performance of the device for its intended use or mechanism of action.

• Bibliographic evaluation: Maytal’s team, composed of clinicians, engineers, and biologists with years of experience in the medical device sector, applies well-established methods validated by multiple Notified Bodies, ensuring objectivity, scientific accuracy, and reliability.

• Clinical studies: Leveraging clinical and methodological expertise, Maytal supports the design and execution of clinical studies (protocols, outcome definition, etc.) through partnerships with established Contract Research Organizations (CROs).

Our detailed services include:

• Defining the clinical evaluation strategy and/or performance validation strategy from the early stages of product development

• Drafting the Clinical Evaluation Plan (CEP), including the State of the Art (SOTA) review and necessary literature search protocols

• Comparative analysis with market products and identification of clinical validation gaps

• Drafting bibliographic clinical evaluation protocols

• Preparing the Clinical Evaluation Report (CER)

• Supporting manufacturer personnel in conducting clinical investigations under MDR:
  
  - Drafting study protocols and associated documents (CRF, investigator brochure, etc.)
  - Managing interactions with ethics committees
  - Liaising with competent authorities and managing adverse events
  - Monitoring, data management, and statistical analysis
  - Preparing the final study report

• Supporting Post-Market Surveillance (PMS) in compliance with international requirements (MDR, IVDR for Europe, SOR for Canada, etc.):
  
  - Drafting Post-Market Clinical Follow-Up (PMCF) or post-market performance follow-up (PMPF) plans for IVDs
  - Collecting data and preparing PMCF/PMPF reports
  - Drafting PMS plans
  - Collecting data and preparing PMS reports (PSURs)