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MEDDEV 2.7.1, which determines the requirements for clinical data evaluation of medical devices to be offered to the EU market, entered into force with its 4th Revision in June 2016.

We have reviewed for you the fourth revision of MEDDEV 2.7.1, which is expected to cause significant changes in clinical evaluation studies. While reviewing the Clinical Data Evaluation Report formats we prepared for manufacturers, we wanted to share with you a few changes that we considered important.

The New Version appears to address the topics listed below in more detail and clarity:

• Stricter rules regarding the frequency of updating the clinical data evaluation report
• Detailed documentation regarding the past experience of the personnel who will perform the clinical evaluation
• More detailed justification in order to prove the equivalence of the device and equivalent devices (competitive products) for which clinical data evaluation is made and a clear indication from which sources the equivalent device information is provided.
• Declaration of impartiality by each medical personnel who checked the clinical evaluation report
• Demonstrating the scientific weight/validity of each clinical data set to be used in clinical data evaluation according to the rating system determined by the manufacturer or the company that will evaluate the clinical data.
• Presenting a detailed discussion on post-market clinical follow-up studies, based on the results of the clinical data evaluation report of the product.

We can summarize the points to be considered in clinical data evaluation reports to be written in accordance with MEDDEV 2.7.1 Rev.4 as follows:

A. It is emphasized that clinical evaluation requirements should apply to all classes of medical devices.

According to the regulation, the content of this evaluation must include

• All medical indications,
• Clinical performance of the device and clinical benefits expected from the device,
• Measures aimed at mitigating or avoiding risks (contraindications, warnings, precautions, post-market clinical follow-up),
• Availability of the device for the desired user profile,
• Instructions for the target patient group (e.g., pediatric or pregnant women) should be available.

B. The fourth revision, which strongly reminds that clinical evaluation should be carried out within the product life cycle, especially during the development phase of the product, also explains the purpose and criteria of clinical evaluation before receiving the CE certificate for the product, and states that it is mandatory to actively update it, and in what cases and frequency it will be done.

Therefore, the new guideline provides clear information on why clinical evaluation should be performed at different life stages of the product.

The main issues to be addressed by the clinical data evaluation to be carried out throughout the life of the device and the reasons for the evaluation are stated in the table below:

Both newly prepared and updated clinical evaluations are generally coordinated with the Notified Body in connection with auditing and certificate renewal, and the characteristics that the person performing the evaluation must have while updating the evaluation are documented in detail.

C. The fourth version of MEDDEV 2.7.1 once again describes how a "clinical evaluation" should be done in main items:

PHASE 1 - Scope: It should be stated which device or device groups, which configuration or size groups the clinical evaluation report will cover. It should be defined in accordance with which Essential Requirements specified in the first annex of the European Union Medical Device Directive will address the clinical performance and safety of the device.
 
PHASE 2 - Device Features: Information about the device under clinical evaluation (indication, contraindication, device description, expected clinical benefits) should be provided.
 
PHASE 3 Equivalent Device Evaluation: MEDDEV 2.7.1 Rev.4 has set more stringent criteria for equivalent device evaluation compared to the previous revision. In order for the devices evaluated to be considered equivalent, they must be highly similar in all three technical, clinical and biological criteria. It needs to be shown in detail how the existing differences will affect the clinical performance of the device. Apart from this, the source from which the information regarding equivalent devices was obtained (whether through a special agreement with the company or from public websites) should be clearly stated in the report.
 
PHASE 4 - Latest Technology: Current treatment methods and alternative methods related to the clinical area where the device is used should be written in detail and the device in question should be compared with other existing methods.
 
PHASE 5 - Literature Search: Which sources will be used for literature scanning, which databases will be searched, which keywords will be used, in what time period, and what kind of filters will be used should be written in detail in the report.
 
PHASE 6 - Clinical Data Analysis: Clinical data selected in accordance with the predetermined literature review methodology must be evaluated in accordance with the rating plan (critical appraisal plan) determined by the manufacturer. Unlike the previous version, Rev.4; It requires that the method to be used for clinical data grading be determined by the manufacturer (or the company performing the clinical evaluation). It must be proven that the analysis is carried out on data sets with appropriate scientific validity. In this context, publications; It should be examined in detail in terms of parameters such as patient population size and profile, randomization methods, and the presence of statistical significance.
 
PHASE 7 - Analysis of Clinical Data in Terms of Risk/Benefit: The Clinical Data Evaluation Report should include a discussion of the adequacy of the following information:

• Adequacy of information obtained from the manufacturer (labeling, IFU, sample materials, etc.),
• The existence of residual risks and uncertainties or unanswered questions; their acceptability for CE-certification and the need to indicate during post-market surveillance activities,
• Requirement for post-sale clinical follow-up (Post Market Clinical Follow-up; PMCF).

In accordance with MEDDEV 2.7.1 Rev.4; It is essential to provide a detailed justification regarding whether or not a post-sale clinical follow-up study should be performed, especially for high-risk devices.

 
PHASE 8 - Determining Whether a Device-Specific Clinical Study Is Required: MEDDEV 2.7.1 Rev.4 ANNEX 2; It provides detailed information about when a device requires clinical study. In summary, if the device; It has been stated that if the technology contains a new technology for which there is not sufficient clinical data and therefore the risk/benefit analysis has insufficient findings in determining side effects and/or there is a possibility of the emergence of new or different purposes of use, an additional clinical study should be conducted.
 
PHASE 9 - Submission of Personnel Qualification: Proving that the control and evaluation of the written clinical evaluation report is carried out by qualified personnel (graduated from a field related to the clinical use of the device; CVs of experts with at least 5 years of experience must be added to the file) and each person who performs the control/evaluation A medical professional must submit a signed statement of interest.
 
PHASE 10 - Report Update Plan: It should be stated how often the clinical evaluation report should be updated (at least once a year for high-risk or new devices; for other devices outside this category, it is recommended to update every 2 years to 5 years; other than this, each update A detailed justification for the plan must be provided).
 
PHASE 11 - Literature Search Result Breakdown: Raw data of the literature search data must be provided (list of excluded sources, justification for exclusion of each article).
 
PHASE 12 - Demonstration of Compliance with the Essential Requirements: It is necessary to demonstrate that compliance with the pre-determined Essential Requirements has been achieved throughout the clinical data evaluation report.

D. One of the most important additions in the latest version is that the following information obtained from the manufacturer should be included in the Clinical Data Evaluation Report:

• Premarket clinical studies
• All clinical data obtained from risk management activities and post-market surveillance activities
• Relevant pre-clinical studies (bench test reports, animal experiments, biocompatibility verification and validation data)

It details how to select the data to be used in clinical evaluation, which sources will be used to obtain reliable data, taking into account pre- and post-sale clinical studies, vigilance data and clinical research design (e.g. scientific databases such as PubMed, EMBASE; vigilance databases such as FDA, MHRA). It has been explained in detail and the articles of a comprehensive analysis have been added along with the determination of post-market clinical follow-up requirements.

E. If, as a result of the updates made in MEDDEV 2.7.1, the Clinical Data Evaluation results show that compliance with the Essential Requirements is not achieved, a special product-specific evaluation must be made in the report.

Get detailed information about our service, which ensures that Clinical Data Evaluation Reports, which have a very important place in the product life cycle, are fully prepared by our experts.