Clinical evaluation

Conducting clinical evaluation is one of the main requirements of MDR 2017/745, which applies to all manufacturers and to all classes and types of medical devices (including class I). Accordingly, no matter what medical devices you sell in the European Union, you need to conduct a clinical evaluation of these products.

According to MDR 2017/745, clinical evaluation of a medical device is a systematic and carefully planned process aimed at the continuous collection of clinical data relating to the clinical use of a medical device, as well as their analysis and evaluation with the aim of continuously monitoring the safety and effectiveness of the device.

Clinical evaluation must be carried out by a suitably qualified person or persons. The main requirements for an expert conducting a clinical evaluation are as follows:

• Education in a medical or related field and a minimum of 5 years of professional experience
• Knowledge of scientific methodology, experience in clinical research and biostatistics
• Documented ability to work with scientific information
• Knowledge of regulatory requirements for medical devices in the European Union
• Experience in writing medical texts (articles, reviews, etc.

Clinical evaluation should be based on a clear scientific methodology, which should be described in a Clinical evaluation plan. The outcome of the clinical evaluation conducted in accordance with this plan is a Clinical evaluation report. The main data analyzed during the clinical assessment are as follows:

• Results of clinical investigations of a medical device
• Results of studies of equivalent medical devices (equivalence must be justified)
• Data published in the scientific literature regarding comparable medical devices

The analysis and conclusions of a clinical assessment must be well structured and scientifically substantiated.

PMCF

PMCF (Post-market clinical follow-up) is the process of continually updating clinical data collected and analyzed as part of a clinical evaluation. Hence, the PMCF is a continuation of the clinical evaluation process at the stage when the product already has a CE mark and is sold in the European Union.

Like clinical evaluation, PMCF requires planning and is conducted based on a Post-Marketing Clinical Followup Plan (PMCF plan). As part of the PMCF, the following data is assessed:

• Data from any clinical investigations conducted during the postmarketing period
• Data on the effectiveness and safety of equivalent and comparable medical devices collected during the reporting period
• Data from the scientific literature regarding the effectiveness and safety of comparable medical products, as well as trends and approaches observed in relevant therapeutic areas.

The processes of clinical evaluation, PMCF and post-marketing surveillance form a single system, the task of which is to continuously monitor the effectiveness and safety of a medical device on the market in the European Union. The system must ensure continued compliance of the medical device with the General Safety and Performance Requirements (GSPR) set out in Annex 1 to MDR 2017/745.

PMS

PMS (Post-market surveillance system) is a system that every manufacturer of medical devices selling their products in the European Union is required to have. Having a PMS for a particular product is a prerequisite that must be met in order to be eligible to apply CE marking to it. This requirement is set out in MDR 2017/745.

The manufacturer is required to plan, implement and document the post-market surveillance system for each product marketed in the EU. The PMS features for each individual product are determined by the product type and class.

The post-market surveillance system must be integrated into the quality management system and is a part of it. Its main goal is the systematic and active collection, analysis and documentation of information relating to the quality, effectiveness and safety of a medical device at the entire post-registration stage of its life cycle.

Based on the results of the PMS processes, the manufacturer determines the need for corrective and preventive actions. In particular, post-marketing surveillance data is used to:

• update the benefit/risk analysis for a medical device
• update clinical assessment
• update other sections of technical documentation
• update instructions for use and labeling
• identify trends regarding the frequency and severity of adverse events
• establish the need to improve product characteristics.

The main PMS documents are the Post-market surveillance plan and Post-market surveillance reports (for class I) or Periodic Safety Update Report or PSUR (for higher classes). The frequency of PMS reporting is determined by the characteristics of the medical device.

Conclusion

The importance of clinical evaluation extends far beyond the initial stages of device development. It forms an inseparable link with PMCF and PMS, collectively shaping a holistic approach to ensuring the ongoing safety and effectiveness of medical devices. Embracing this holistic view not only meets regulatory requirements but, more importantly, fosters a culture of continuous improvement and commitment to patient welfare.