MedDev 2.7.1 Rev 4, Clinical Evaluation

MedDev 2.7.1 Rev 4 Clinical Evaluation

Medical Device Clinical Evaluation Report is required to demonstrate the safety and performance of a medical device during its clinical use. It can be defined as a systematic, ongoing process to analyze and evaluate the clinical data collected either from the clinical investigation of the device or from the results of studies done on equivalent or similar devices. It is an integral part of the conformity assessment procedure for obtaining CE marking for the medical device.

All medical device manufacturers need to go through this procedure to release their devices in the EU market. To conduct a systematic evaluation, define the scope of assessment based on the general safety and performance requirements and set up a plan. The next step is to identify the clinical data provided by the manufacturer (such as clinical investigation reports of the device), from the literature available about similar devices, or both.

The data thus identified should be appraised based on its quality, relevance and clinical significance and should be analyzed to determine its compliance with general safety and performance requirements. Finally, the MDR clinical evaluation report (CER) should be prepared to summarize the evaluation of relevant clinical data and its output.

Though medical device clinical evaluation is first conducted to obtain initial medical device CE marking, It should be actively updated whenever new information is received from PMS. The frequency of updating of CER depends on the risk class of the device, how well it is established in the market, design changes of the device, and unanswered questions about the device.

In addition, we provide the medical device clinical evaluation service, which is required to demonstrate the safety and performance of a medical device during its clinical use & it also includes the MDR clinical evaluation report.

Clinical Evaluation Report

The Clinical Evaluation Report is required for all medical devices in Europe. It contains an analysis of both pre-and post-market clinical data related to the device and conclusions drawn from the clinical evaluation of the medical device. Therefore, it must be submitted to the notified body as part of the device’s technical file.

The Clinical Evaluation Report should include:

The general device description, its classification, intended use, warnings, contraindications, clinical background, current knowledge, state of the art, type of evaluation, equivalence demonstration, data generated held by the manufacturer such as preclinical study reports, outcomes of PMS and PMCF studies, data retrieved from literature, appraisal and analysis of data, and finally the conclusion and date of subsequent clinical evaluation.
The clinical evaluation report should also include references to the documents that support the clinical data provided. It should be actively updated based on the conclusion from PMS, PMCF studies and risk analysis.

MDR Article 61 and MedDev 2.7.1 Rev 4

MedDev 2.7.1 Rev 4 is a guidance document for the clinical evaluation of medical devices released by the European Commission on 1 July 2016.

It gives the general principles of clinical assessment and explains different medical device clinical evaluation stages in detail. It also specifies how frequently the Clinical evaluation report should be updated. The qualification of evaluators, the rules for demonstrating equivalence with other medical devices, the establishment of state of art, whether a clinical investigation is necessary, and the role of the notified body in the assessment of the clinical evaluation report.

EN ISO 13485:2016-Medical Devices Quality Management Systems Requirements for Regulatory Purposes

This standard provides the requirements of a quality management system that can be used by an organization involved in one or more stages of the life cycle of a medical device. As part of design and development validation, the organization will perform clinical evaluations or performance evaluations of the medical device following applicable regulatory requirements.

Challenges in completing MDR Clinical Evaluation

MDR Clinical Evaluation is an ongoing activity throughout the product life cycle. Clinical Assessment is not a standalone activity. Monitoring and regularly gathering and updating information on critical processes, such as Post-market surveillance and risk management activities. Manufacturers cannot predicate or estimate the time required to carry out a complete Clinical Evaluation Report or how many persons must be deputed to complete one product. If they have multiple devices, the human resources requirements and time will be. The result is staff shortages and the non-availability of an experienced workforce.

First, manufacturers should perform a GAP analysis on their existing CER with the help of our consultants; what is the missing, or what weaknesses does it exhibit? Where is the system used to develop and update CERs failing the manufacturer? Is this development and update process inconsistent across all the products? Is any Notified Body comments pending with the manufacturer?

Request for Clinical Evaluation Proposal

MedDev 2.7.1 Rev 4 - Additional Information's

Review of MDR CER by Notified Body

The notified body does not have to be involved in class I medical devices (except for sterile devices, reusable surgical instruments, and devices with measuring functions).

For other classes (class IIa, IIb, and Class III), the notified body will review the manufacturers’ clinical evaluation reports and supporting data as part of the clinical assessment procedure.

They verify and conclude whether the manufacturer followed relevant procedures, performs risk analysis and identify undesirable side effects, provides proper justification for benefits, adequately identifies, appraises, and analyze the clinical data, provides sufficient clinical evidence related to safety and performance, and demonstrate the equivalence for the device under evaluation.

They also examine:

whether PMS plan is provided and if it is adequate and appropriate,
the areas in the clinical evaluation which need to be confirmed using PMCF,
whether the PMCF plan is correct,
Justification is given in case PMCF is not necessary,
identified the sources of data from the PMS system,
whether risks are acceptable when weighed against the benefits and
clinical performance of the device is achieved.

The notified body will confirm the validity of the manufacturer’s justification, estimate the associated risks, and finally write a Clinical Evaluation Assessment Report(CEAR) based on the assessment done.

I3CGlobal team for MDR CER Documentation

We can help manufacturers prepare fully compliant CER, as we are specialised in reviewing medical device clinical data. We can:

Provide templates for clinical evaluation compilation.
Develop procedures for clinical evaluation.
Perform a methodological scientific literature search to gather the clinical data applicable to a device and prepare literature review reports.
Appraise, analyse the clinical data and compile the CER in compliance with EU requirements.
Also, guide the manufacturers for conducting PMS and PMCF studies (if necessary) and prepare PMSR/ PSUR and PMCF reports.

Our Pricing

Class I	200000 INR	NA
Class Is /Im/Ir	400000 INR	Free Technical File & NB Coordination till CE Certification
Class IIa	600000 INR	Free Technical File & NB Coordination till CE Certification
Class IIb	700000 INR	Free Technical File & NB Coordination till CE Certification
Class III	800000 INR	Free Technical File & NB Coordination till CE Certification

The fees applicable for a single device with single intended use made for a single design.

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