2017/745 Medical Device Regulation VI. The MDR Clinical Evaluation, referred to in the MDR section, sets out the requirements for clinical evaluation of the medical device and, where appropriate, for clinical investigation.

A detailed evaluation of clinical data with sufficient clinical evidence of adverse effects and the acceptability of the benefit-risk ratio to confirm the clinical safety and performance of the medical device is called Clinical Evaluation. The clinical evaluation process should be arranged for all medical devices, regardless of the risk class of the medical device (Class I, Class II and Class III). (applies to both new devices and old devices.)

A well-designed and clearly documented clinical evaluation plan (CEP) and clinical evaluation report (CER) are required in order to plan and appropriately manage clinical evaluation and established evidence.

Clinical Evaluation is a systematic and planned process to evaluate the safety and performance of a medical device. The main purpose of the Clinical Evaluation is to demonstrate the compliance of the medical device with the General Safety and Performance Requirements (GSPR) listed in Annex I to the MDR and to prove that the benefit-risk profile of the device continues to be acceptable.

The key considerations and steps involved in clinical evaluation of medical devices are:

1.Clinical Evaluation Plan (CEP): A clinical evaluation plan should be developed before starting the evaluation process. To evaluate the clinical performance of the device, its objectives, methodology, data sources, and analysis plan should be outlined. Clinical assessment plan requirements are defined in MDR Annex XIV Part A.
2.Clinical Data Collection: Clinical data should be collected from many processes for the clinical evaluation process. Example; clinical trials, post-market surveillance, data from scientific literature and other valid sources, information on commercially available and certified equivalent products, etc. In the collection of these clinical data collected from different processes, the intended use of the medical device and the target population should be considered.
3.Clinical Data Analysis: Clinical data collected from different processes and sources; should be analyzed to determine device safety, performance, and clinical efficacy. Statistical analysis and other appropriate methods should be used to interpret the data and draw meaningful conclusions.
4.Risk Assessment: The clinical assessment should include a comprehensive assessment of the risks and benefits of the device. Device-related risks should be identified, analyzed and compared with expected benefits to provide an overall positive benefit-risk profile. In doing so, the clinical benefits of the device must also be evaluated and defenses made with strong evidence.
5.Clinical Evaluation Report (CER): A comprehensive clinical evaluation report should be prepared to document the findings of all the processes mentioned above. CER; summarize clinical data, risk assessment, and conclusions regarding device safety and performance.
6.Post-Market Surveillance: After a medical device is put on the market, an effective market surveillance process is essential to assess the condition of the device in market conditions and to monitor and evaluate feedback from the market. This process; It helps to monitor for new risks, security issues, and performance issues and identify device design modifications where necessary.
7.Updates and Re-evaluation: The clinical evaluation process is a living and dynamic process, it should be reviewed at specified intervals and kept up-to-date. Significant changes in device design, indications, or safety profile may require reassessment and an updated CER.

Do not hesitate to contact the Infigen Consultancy expert team during the creation and evaluation of this complex and challenging process. Experienced Infigen Consultancy, which has a comprehensive understanding of MDR's requirements and has been dealing with certification processes in the medical device industry for 20 years, can assist you in your work.