Clinical evaluation

Clinical evaluation is the procedure for collecting, evaluating and analysing clinical data on a medical device to verify that the clinical evidence proves the safety and effectiveness of the medical device.

What is a clinical evaluation for medical devices?

Clinical evaluation for medical devices is the systematic process of assessing the clinical performance, safety, and efficacy of a medical device. The clinical evaluation is the responsibility of every manufacturer of a medical device, regardless of the declared class of the medical device. It is a continuous procedure, with reliable methodology, to collect, assess and analyse clinical data on the medical device, to verify whether the clinical evidence provided confirms the conformity of the medical device with the essential requirements for safety and efficacy in use in accordance with the instructions provided by the manufacturer. The clinical evaluation makes it possible to determine the level of acceptability of the benefit-risk balance under the conditions of use of the medical device.

On what basis the clinical evaluation is performed?

The clinical evaluation shall be based on clinical data:

  • a critical analysis of the scientific literature currently available concerning the safety, performance, design characteristics and intended use of the product, where equivalence of the product with the product to which the data relates has been demonstrated.
  • a critical evaluation of the results of all clinical trials,
  • a critical overall assessment of the above mentioned data.

The clinical assessment report (CER) is one of the documents in the technical dossier.

Why is clinical evaluation important for medical devices?

Clinical evaluation is crucial for ensuring the safety and effectiveness of medical devices before they are marketed and used in clinical practice. It provides scientific evidence to support regulatory approval and helps assess the device’s performance in real-world clinical settings. By identifying potential risks and benefits, clinical evaluation contributes to making informed decisions about the device’s use, ultimately safeguarding patient health and well-being.

What are the steps in clinical evaluation for medical devices?

The steps involved in conducting a clinical evaluation for medical devices typically include:

  • Defining the device’s intended use and clinical indications.
  • Conducting a systematic literature review to gather relevant clinical data.
  • Collecting and analyzing clinical data from various sources, such as clinical studies, post-market surveillance, and registries.
  • Assessing the clinical performance, safety, and effectiveness of the device.
  • Documenting the clinical evaluation process and findings in a comprehensive clinical evaluation report (CER).
  • Updating the clinical evaluation regularly throughout the device’s lifecycle.

Who is responsible for conducting clinical evaluations for medical devices?

The responsibility for conducting clinical evaluations for medical devices typically lies with the manufacturer of the device. This may involve a multidisciplinary team of clinical experts, regulatory affairs professionals, statisticians, and medical writers who collaborate to design, implement, and document the clinical evaluation process. In some cases, manufacturers may also seek assistance from external consultants or clinical research organizations (CROs) with expertise in clinical evaluation and regulatory compliance.

What are the requirements for clinical data in medical device clinical evaluations?

The requirements for clinical data in medical device clinical evaluations vary depending on regulatory requirements and the device’s risk classification. Generally, clinical data should be robust, reliable, and relevant to demonstrate the device’s safety, performance, and effectiveness for its intended use. This may include data from clinical studies, post-market surveillance, literature reviews, and expert opinions. The clinical data should be scientifically valid, collected using appropriate methodologies, and sufficiently detailed.

What are the best practices for ensuring compliance with MDR for clinical evaluation of medical devices?

To ensure compliance with clinical evaluation regulations for medical devices, manufacturers should follow best practices such as:

  • Establishing a robust quality management system (QMS) to oversee the clinical evaluation process.
  • Conducting thorough literature reviews to identify relevant clinical data sources.
  • Designing well-controlled clinical trials, if required.
  • Documenting the clinical evaluation process and findings in a comprehensive clinical evaluation report (CER).
  • Regularly updating the clinical evaluation to incorporate new data and address any emerging safety or efficacy concerns.
  • Maintaining accurate reporting of data and adherence to ethical standards
  • navigate complex regulatory requirements and ensure compliance with applicable regulations and standards.