2 min

A comprehensive overview of pre-clinical and clinical evaluation processes

Clinical evaluations, an important and challenging expect of your Technical File

 

In the dynamic realm of medical device development, the journey from conceptualization to market availability is intricate and demands meticulous evaluation at various stages. This text explains the processes of pre-clinical and clinical evaluations, essential components in ensuring the safety, performance, and regulatory compliance of medical devices. 

 

Pre-clinical evaluation  

For bench testing, simulation testing and animal studies, if applicable, a description should be present on the goals, methodology, analysis and results of the tests or studies. A pre-clinical literature review should be present, describing the clinical background to which the device is situated.  

Note: this is a literature review to embed the device in the current clinical practice, its use, alternatives, state-of-the-art etc.  

 

Clinical evaluation  

A clinical investigation is required if conformity to the general safety and performance requirements cannot be fully covered by a literature review, based on investigations of equivalent devices. In case of class III, a clinical investigation is almost always required. It is necessary to show conformity of the device with the general safety and performance requirements and all performance claims and intended clinical benefits, and to collect information on hazards, risks, possible side-effects and usability. 

 

If the clinical data is in that case based on a clinical investigation of an equivalent device: 

  • For class III, a contract should be in place with the manufacturer of the equivalent device, allowing ongoing and full access to the TD of that device. In that case, a post-market clinical follow-up is always required.  
  • For other classes, if clinical data is based on equivalency, this should be justified in-depth and it should be described and substantiated how access to relevant information from the equivalent device is ensured.  

In case of a review of the available literature and data, a signed and dated report with the following information needs to be present:  

  • Description of the methodology of the literature review (scope, data sources, search strategy, justification that all publications, also the ones with a negative result, are included, exclusion criteria).  
  • Justification of equivalence of the current device with the devices described in the literature. 
  • Description how references are weighed for the final conclusion (considering robustness methodology, expertise etc.)  
  • Analysis and conclusions (Are performance claims, benefits etc. backed up? Is the scope completely covered or is a clinical investigation required for certain aspects?) 
  • Full versions of selected papers.  

If a clinical investigation is necessary, this should in principle have been conducted in conformity with EN ISO 14155 and in conformity with article 62 to 84 of the MDR, as applicable. Please bear in mind that all clinical investigations in human subjects need not only be approved by a METC or other relevant ethical body, but also need to be notified to the competent authority of the country were the study is conducted.

 

Again, a signed and dated report with the following information needs to be present:  

  • Copy of the research protocol as submitted to the ethical commission / competent authority. 
  • Copy of approval letters.  
  • Copies of submitted amendments during the investigation.  
  • Clinical investigation plan with an explanation of amendments to the original approved protocol.  
  • Copy of the final report (summary, introduction, materials and methods, results, conclusions, risk / benefit assessment), dated and signed by the manufacturer and the principal investigator (of each investigation site, if applicable).  
  • Appendix with a list of the investigation site and investigators, monitors, statisticians etc. and the declaration of approval of the ethical commission of each site.  
 

In case the clinical evaluation is based on non-clinical data, a full justification meeting the requirements of article 61.10 should be present, including a referral to the non-clinical data supporting safety and performance and an appraisal on how this data is able to show that the device is in conformity with GSPR 1 and 8. This should be documented in a clinical evaluation report. 

 

We understand it is a lot of work, but we trust this overview gives you the right direction to bring a safe product on the market. If you have any question, do not hesitate to contact us via medical@kiwa.com.