In medical research and the healthcare sector, the terms clinical evaluation vs clinical investigations are frequently used interchangeably, and many manufacturers find it challenging to distinguish between the two under regulations.
Instead, they pertain to several practices specially made to ensure the effectiveness and safety of drugs, medical equipment, and treatments.
A Clinical Evaluation should be planned, carried out, and documented by manufacturers for their medical devices as a part of the CE certification procedure, according to the EU Medical Device Regulation 2017/745 (EU MDR).
As per MDR Article 61(1), this assessment should verify that the device satisfies pertinent general safety and performance standards under real-life conditions.
For conformity assessment, clinical investigations must be planned, authorised, conducted, documented, and reported in accordance with the provisions of this article, Articles 63 to 80, and the acts adopted pursuant to Article 81 and Annex XV. Many manufacturers find it difficult to discern between a clinical investigation and a clinical evaluation.
Clinical Evaluation
The EU MDR defines clinical evaluation as a systematic, planned procedure for continuously generating, gathering, analysing, and assessing clinical data about a device to verify the product’s effectiveness and safety, as well as the clinical benefits that the manufacturer claims.
Medical device manufacturers must conduct a clinical evaluation of their devices in accordance with the EU MDR throughout the process of the CE marking procedure.
The clinical evaluation will be conducted in compliance with EU MDR Article 61 and Annex XIV to
Identify the intended use, related clinical advantages, usage guidelines, and contraindications of the device.
Determine attainable results for the same patient populations with alternative state-of-the-art.
Explain the data sources used.
Develop findings on safety performance, risk-benefit analysis,
Justify the completeness of the data supporting the device’s variations and combinations, prospective patient demographics, and indications.
The device’s safety and functionality in real-world scenarios are demonstrated via a clinical evaluation. It makes safety, performance demonstrations, regulatory compliance, and post-market surveillance easier.
One essential prerequisite for regulatory clearance of all medical devices under the MDR is a properly organized Clinical Evaluation Report. For all different kinds of medical devices, components, and chemicals, the European Union market requires the Clinical Evaluation Report (CER), which offers comprehensive information about a product over its whole life cycle.
The CER document, which is a crucial prerequisite for obtaining CE certification, is created based on the clinical examination of the medical equipment.
Clinical investigations
Research that examines novel diagnostic procedures and therapeutic approaches and assesses their impact on human health outcomes is known as clinical trials. They evaluate the general efficacy, safety, and performance of a specific medical intervention, such as a drug, piece of equipment, or therapy.
Clinical investigations are clinical trials that use medical devices and purpose of this is to establish and validate clinical safety, which includes preventing and minimizing risks, errors, and injuries that may occur to patients and users.
According to ISO 14155, a clinical investigation is any systematic study with one or more human participants that attempts to evaluate the clinical performance, efficacy, or safety of a medical device. Strict scientific guidelines must be adhered to safeguard people and generate trustworthy scientific findings.
This process gathers the most recent information on the effectiveness and safety of devices through human studies. These trials are essential for obtaining regulatory approval and are often divided into different stages
Stages of Clinical Investigation
The objective is to produce solid, evidence-based data that will support regulatory approval and guide clinical practice, guaranteeing therapeutic benefits and patient safety. Benefits include
Access to cutting-edge treatments for participants.
Development of medical knowledge and innovation
Verifying the efficacy and safety of novel techniques
Improving healthcare outcomes worldwide.
Clinical evaluation and clinical Investigation difference
Conclusion
A Clinical Evaluation is a theoretical and scientific assessment and appraisal of existing data from numerous sources of clinical data, indicating that human subjects are not directly involve.
A clinical investigation, on the other hand, is research that shows the effectiveness and safety of a medical devices by using it on patients. Clinical evaluation and clinical investigations are related, data from clinical investigations is frequently used in clinical evaluations.
Both clinical evaluation and clinical investigation play important roles in developing the medical field and ensuring patient safety.
Aswathy G
Jr. Consultant
Clinical Evaluation
MDR