A Complete Guide for the Clinical Evaluation of Medical Devices
Medical devices applying for ce certification must undergo a clinical evaluation to ensure that they are safe and effective – both before being placed on the market, as well as during their lifecycle. This entails a methodical review of the patient and device data to ensure that it is safe and functioning as intended. Crucial aspects of it are the following: Regulatory compliance, comprehensive literature review including bench testing and equivalence justification. This article will address these points and highlight the significance of both Meddev 2.7.1 rev 4, MDR Article 61 as well as continuous evaluation using CER annual reports
MDR art 61and Meddev 2.7.1 rev4
Meddev 2.7.1 rev 4 is an essential regulatory guidance document for the clinical evaluation of medical devices in Europe It sets forth the steps and precautions to be taken when carrying out clinical evaluations to ensure these are carried out by good scientific practice, conforming with regulatory expectations. This means manufacturers know what levels of clinical evidence are expected or in other words, the level and extent to which data needs to be covered.
MDR Article 61 for clinical evaluation must be followed for MDR 2017/745 compliance which requires input from both clinical investigations and general market principles (clinical evidence). It requires that manufacturers establish the safety and performance of their devices by providing clinical data drawn from pre-market trials, scientific evidence or outcomes studies. Article 61 underlines the necessity for a comprehensive and continuous clinical assessment procedure throughout the whole lifecycle of the device.
Literature Search
A thorough literature search is the foundation of any clinical evaluation process. This includes a structured method of collating and appraising existing clinical information for the medical device in question, (assigns) The objective is to collect enough data which would allow verification of the safety and effectiveness without necessarily performing a new clinical investigation. Important stages in literature searching are: –
Defining Search Criteria: Clear and comprehensive search criteria such as keywords, databases, or timeframes should be defined to optimize the effectiveness of a methodical review.
Choosing Databases: Using well-known databases in the medical and scientific field like Pubmed, Embase or Cochrane Library to search for related literature.
Quality Assessment: Quality assessment of identified studies was performed to ensure that only high-quality and relevant data were added in clinical evaluation.
Data extraction and analysis: Extracting data from selected studies by the same systematic method used for clinical evaluation.
Clinical Evaluation by Bench Testing
Another essential part of the process when it comes to clinical evaluation is bench testing. Testing the medical device inside a closed laboratory environment under those controlled conditions to check how well it performs in terms of its performance on durability and safety. Bench testing can provide information on the following:
Characterisation of Mechanical & Physical Properties (Strength/Flexibility associated with the device). Biocompatibility: Materials the device is made of causing no adverse reactions upon contact with human tissue.
Testing: Ensuring the device performs as intended in conditions similar to actual use
Clinical data is key, but bench testing provides that added real-world assessment of device performance and safety.
Substitute Device Rationale
If a new medical device is substantially equivalent to an existing one, makers can cite clinical data supporting the equivalent for their assessment. By utilising pre-existing evidence, this technique may well save time and resources. Nonetheless, a substantial justification has to be given by manufacturers that provide devices as equivalent are:
Technical Specifications: Showing the devices have identical design, materials and manufacturing processes. This includes Equivalent clinical performance, i.e. demonstration that the devices lead to comparable clinical results. This includes the Risk Profile, which ensures that both devices have similar safety profiles and risks. A robust rationale for equivalence is crucial to demonstrate that the clinical data generated concerning a predicate device are pertinent and applicable in the case of new devices.
Clinical Evaluation Report CER
A Clinical Evaluation Report (CER) is produced at the end of this evaluation process. The document is a complete summary, incorporating information on clinical data; findings of literature searches; and testing performed to verify that the device functions similarly to the equivalent devices submitted instead of unique samples (i.e., “equivalent”) for reasons described concerning Section 7.4 above A systematic CER consists of a CEP which describes the device and its application, stating what was being assessed. The clinical data should be presented in detail, encompassing literature searches and (if applicable) clinical investigations and post-market surveillance.
Analysis and Conclusion: Analyse the data critically making a discussion regarding Device safety and performance with a conclusion based on evidence.
Annual CER Report
Class IIA, IIB and III medical device manufacturers are obliged to keep the CER current to ensure that their devices remain safe and effective. The prospective, active annual CER report validates the newest clinical data which includes any therapy concerns that arise from adverse events including expert reviews and post-market surveillance findings. This ongoing assessment helps to catch early signs of problems and adjust plans accordingly.
Conclusion
I3CGLOBAL supports medical device firms around the globe with a scientific-based approach to quantify and demonstrate evidence of safety, and clinical performance, with an assurance of NB approval by following guidelines such as Meddev 2.7.1 rev 4 and MDR Article 61. We demonstrate device’s safety and performance to manufacturers are warranted in compiling exhaustive clinical evaluation reports through rigorous literature searching, bench testing and justifying the use of an equivalent device to facilitate NB approval.