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Clinical evaluation report writing services for new and those under transition.

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Clinical Evaluation Report For Medical Devices

New EU MDR Article 61, section 12 and Annex XIV – Part A, section 4 state the requirement for a clinical evaluation report for medical devices. Complete clinical evidence collected during the clinical evaluation process is to be documented in a CER and it shall be a part of the technical documentation which will support the assessment of the conformity of the device.

 

MEDDEV 2.7/1 Rev.4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under regulation for Clinical Evaluation, and Stage 4 states the requirement of a CER. As per this guidance, the CER report should contain enough information to be read and understood by an independent party such as a regulatory authority or notified body.

 

Thus, it should provide enough detail for understanding the search criteria adopted by the evaluators, available data, all assumptions made, and all conclusions reached. To obtain CE Certification for medical devices, the applicant must have a thorough clinical evaluation report included as part of the Technical Documentation. No matter what the risk class of the device.

 

The EU 2017/745 has specific requirements for medical device clinical evaluation report documentation and data analysis. I3CGLOBAL is one of the top talented service providers.

 

A clinical evaluation report is a living document that needs to be updated during the medical devices lifespan. When new information about your device becomes available through post-market surveillance or a fresh literature search, the CER must be revised to reflect this.

 

Even if no new information is received, your report must be updated as per the internal clinical evaluation procedure. The clinical evaluation report for Class III or Class IIb implanted devices must be updated annually. The medical device CER Report must be updated every two to five years for devices that pose no major risk.

With our CER Experts, you can trust that your clinical evaluation report is in capable hands, allowing your team to focus on other critical aspects of your business. By leveraging the I3CGlobal expertise, manufacturers can save precious employee productive time and achieve CE Certification faster.

How to create a good Medical Device CER?

The fundamental rule behind a good Clinical Evaluation Report is as follows:

 

  • Should comply with MDR Article 61
  • Should follow MEDDEV 2.7.1 Rev. 4 guidelines
  • The medical device CER must be objective, regardless of whether the data is positive or negative
  • MDR CER Report should be thorough enough to build confidence among NB reviewers and subject experts
  • The CER for established devices can rely on existing market data, whereas novel devices require data from similar and equivalent devices.

Step 1: Identify the scope of CER.

The scope of the clinical evaluation should include the identification of devices covered by this CER, products, models, sizes, software versions, accessories, whether it is on the market, since when, in what regions, history of the device, in case of an update in the plan, including date of past modifications with reasons and description, sales volumes, changes since the last report, and identification of the sections of the CER that are concerned with the new information and have been modified should be mentioned.

Step 2: CER Planning

To plan a sound method for identifying, collecting, and analyzing the clinical data with the proper schedule and clinical evaluation team. Also, to develop the scope of the clinical evaluation to be conducted on the medical device.

Step 3: Data generated and held by the manufacturer.

All premarket clinical investigations such as bench test reports include verification and validation data and clinical data generated from risk management activities and the PMS programs.

Step 4: Background, current knowledge, state of the art

A review of the current knowledge/state of the art needed for the proper conduct of the appraisal and analysis of the device’s clinical data under evaluation and the equivalent device.

 

Summary and justification of the literature search strategy applied for retrieving information on current knowledge, including sources, keywords, selection criteria used, quality control measures, results, number, and type of literature, were pertinent. Appraisal criteria were also used to summarize.

Step 5: Clinical data from the literature

The primary plan is to identify three key sources of data that can be in a clinical evaluation report. They are.  

 

  1. Trustworthy data /study comments published in medical journals. 
  2. Unpublished, internal data. 
  3. Complaint/post-market surveillance data. 
  4. registry data (for class 111 devices)

 

It is determining search criteria. 

 

Develop a well-defined plan of action (SOP) for searching the literature to make sure you attempt to find all possible data relevant to the device in question. The plan should consist of inclusion and exclusion criteria framed based on your device’s complexities and avoid analyzing the same data from multiple sources and reducing time searching.

Step 6: Summary and appraisal of data

Assess the overall quality of data that meets inclusion and exclusion criteria. The analysis of data allows determining how much merit the data bring towards the conclusion.

 

MEDDEV 2.7.1 Rev 4 Appendix C and D of the guidelines can be referred to understand more about suitability criteria and grading system.

Step 7: Complete Analysis

Analyzing the data in terms of their safety and performance is a big challenge because the quality of clinical data varies widely from study to study based on Safety, Risk Benefit profile, Performance & Acceptability of side effects.

 

  • The Clinical Evaluation Report should consider potential risks posed by the device that has been identified in the risk management report. All possible risks and risk control measures from the risk management report would need to be addressed in the CER conclusion.
  • Information about study population and diagnoses, intended purpose, adverse events should be analyzed in detail.

 

Presentation of Clinical study data with positive and negative approaches is highly advisable to present in CER. They are (a) Text-based summaries of individual studies or of individual endpoints (b) Visual summaries of pooled data. It is important to have a procedure that clearly defines your methodology followed in analyzing the data.

How to conclude a clinical evaluation report?

Article 61 and MEDDEV 2.7.1 Rev 4 guidelines must write precise conclusions to demonstrate conformity with the relevant general safety and performance requirements. It should address the following in detail.

 

  • According to current knowledge or state of the art in the medical fields concerned and according to available medical alternatives, the benefit-risk profile’s acceptability is concerned.
  • Adequacy of the manufacturer’s information materials, if the intended purpose and risk reduction measures are adequate, discrepancies.
  • The suitability of the device for human usage is to be demonstrated via usability engineering accepts. The user manual or information for use (IFU) must be circulated along with the device.
  • Level of acceptance with manufacturer claims and foreseen discrepancies.
  • Any inconsistence with supplied documents and clinical data must be detailed and explained regards with current knowledge and state of art
  • Unanswered questions or uncertainties derived during risk-benefit analysis and later accepted post-data interpretation of PMS results must be explained and justified thoroughly.
  • Several registries have been set up around the globe to record device-specific outcomes. However, the quality of these registries varies considerably. The conclusion must explain if you excluded some parts due to language problems or any other reason.
  • Data collected and analyzed by field staff must be detailed in CER
  • The conclusion must have an open debate and a walk-through to your Post Market Surveillance Data as part of the in-house study data collected from the previous period. They are mainly abstracting from international medical meetings, ongoing clinical studies, presentations by experts, clinical surveys, Google Scholar, and Post Market Clinical Follow-Up Study data.

MDR CER Annual Update

Many manufacturers assume that the Clinical Evaluation Report is done only once, but the reality is a big NO. It’s important to realize that the entire process including the report writing should be repeated on a regular basis. Any significant changes which affect the initial collection of data should be recorded, and the CER be updated accordingly.

 

The manufacturer should actively collect information from post-market experiences with their devices based on a PMS plan.  Relevant data collected through the PMS should be used to update any relevant part of the CER. Updated clinical evaluation report to be submitted to Notified Body or competent authorities when requested or during annual surveillance audit

Medical Device CER Contents

Based on the device’s risk category, the Clinical Evaluation Report can be simple or quite extensive. The CER is a major portion of the technical file even though it is a stand-alone document and is required for all medical devices regardless of classification.

 

It provides evidence that the device has undergone rigorous evaluation or, in many cases, compared to research done for other substantially equivalent devices already on the market. This includes data specific to the product in question, and any data relating to devices claimed as equivalent by the manufacturer.

 

It contains enough information to be read and understood by an independent party like a regulatory authority or a notified body. Hence, it provides sufficient details for understanding the search criteria adopted, available data, all assumptions made, and all conclusions reached. The general table of contents as per Rev 4 is below.

 

  • Summary
  • Scope of the clinical evaluation
  • General details (manufacturer name & address, responsible person)
  • Device details (description, name, models, variants, intended purpose, risk class, CE marking status, contraindications, warnings, precautions, Identification of changes from the previous version is already in the market)
  • Clinical background, current knowledge, State of Art
  • The device under evaluation (Type of evaluation based on available scientific literature, clinical investigations, etc.)
  • Demonstration of equivalence (If equivalency is claimed)
  • Identification of pertinent data (literature, clinical investigations, PMS, PMCF data)
  • Data generated and held by the manufacturer (PMS and its outcome, PMCF and its outcome, pre-clinical studies, bio-compatibility testing, bench testing, electrical safety, software verification & validation, scientific literature data
  • Summary and appraisal of clinical data.
  • Analysis of clinical data (based on safety, acceptable risk-benefit profile, performance, acceptability of side-effects)
  • Clinical Evaluation report conclusion
  • Qualification of the responsible evaluators
  • Date of next clinical evaluation

Clinical Evaluation Report Consultants

The I3CGlobal team is here to assist you in preparing Clinical Evaluation Reports (CERs) for your Medical Device, regardless of its risk class. We apply Article 61 and Annex XIV of the Medical Device Regulation (MDR) and MEDDEV 2.7/1 Rev 4 guidelines to ensure that your CER meets all necessary requirements.

 

CER documentation may seem simple, but it is a complex and resource-intensive task. It requires a deep understanding of regulatory requirements, clinical data analysis, and risk assessment. Our team of experts is well-equipped to handle these complexities, ensuring that your CER is comprehensive, accurate, and compliant.

 

We understand the importance of CERs in demonstrating the safety and performance of your medical device. That’s why we take a meticulous approach to every step of the CER documentation, from data collection and analysis to report writing and NB submission.

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