What is Clinical Evaluation?

Clinical Evaluation Report [MDR & MEDDEV]

New EU MDR Regulation 2017/745, Chapter VI annex 61 mandates Clinical Evaluation Report to be submitted along with Technical File to demonstrate safety and performance of the medical device based on intended use claimed by the manufacturer.

European commission released MEDDEV 2.7/4 Revision 4 guidelines explains in details about the process of conduct of Clinical evaluation and development of Clinical Evaluation Report (CER).

Depends on the device; 10 - 15 numbers of articles discussing Intended use, patient population, user environment, Contraindication, Warning, Material suitability, Device Safety & Residual Risks.

Yes, the full text of the selected articles must be attached in the CER documentation. Since, we are not modifying the content of the article, it does not violate copyright law.

Yes, expert in the field can do indepth literature search using relevant key words and analysis the data. Consultants and medical writers with previous experience also suggested.

Keywords are defined as words which searchers enter the search engine. Key words are selected form various factors mainly from indication of use, device material characteristics, safety aspects, usage significance, State of art Technology used and residual risks etc.

Yes, it can be done, if it is relevant to the medical device under the scope.

Generally, a good CER with all consolidated supporting documents will be around 300-600 pages, CER alone will be around 15 to 20 pages.

Post Market Surveillance provides the data post sales through various sources on the similar type of device and the device under the scope.

PMCF provide the data only on the device under scope.

Clinical evaluation is continuing process which requires updation depend on the risk classification of the device. While updating PMS and PMCF is one of the bases, if during process any incident observe with subjected device or any similar device related risk and literature steps taken to avoid such incident needs to be analyze and appraise using evaluation..

It is practically not possible to conduct investigation considering cost and legal requirements, but at the same time it is important that device should be clinically proven for safe and effective. If an equivalent US FDA or EU approved device in the market helps to proves device safety and effectiveness with respect to technical, clinical and biological parameters.

Equivalent device data are also appraised and analyzed and recorded give more value edition to CERs.

Published data such as IFU, Product Brochures and Specifications, CE Certificate, 510(k) details are easily available on public domains or manufacturer website. If the device has undergone any trial that can be found on https://clinicaltrials.gov/ website.

If no data of equivalent device, appropriate justification with the PMS covering PMCF obtained for the device under scope.

  • Medical Device variants and construction features not covered in the Evaluation.
  • Equivalent device data not sufficient or no justification provided
  • No data covering state of art and current knowledge and technology
  • No enough and robust justification for any deviation from Meddev 2.7.1/ Rev.4 concepts

All sources of appropriate data are ok. Among these PUBMED provides the maximum literature search relevant to the medical device under the question.

CER is a part of EU Medical Device Regulation(MDD) whereas 510k is that of the US FDA. Ideally, that is not acceptable, however data from 510(k) can be added in the CER.

No. They will not assure the safety and efficacy of the device for a large population. Only the data obtained from PMS and PMCF can assure that the device is safe for use, as per MEDDEV 2.7/1 guideline, literature evaluation is accepted by the notified body.

The residual risk of the medical device is considered while conducting PMS and PMCF studies. In other way, it is directly related to risk analysis as with the help of clinical evaluation manufacturer should prove device safety and effectiveness which should develop literature to be analyze and appraised for residual risk identified after risk analysis. Warnings, indications, side effects, biocompatibility issues- the overall safety of the devices are assessed from the Risk analysis.

Contraindication and warning of the medical device mentioned in IFU or User Manual must be considered while performing data research. In other way around IFU or user manual must be modified based on the outcome of Evaluation.

Yes. The Notified Body will inform if they require a clinical trial in the below situations. data are insufficient to prove the medical device safety and performance

  • where the clinical evidences and clinical data not relevant and accurate to the device in question.
  • If the device is new with respect to technology,
  • If the device is new with respect to use, material of Construction and application
  • No similar device is available in the market
  • Multiple recalls on similar device is reported.

The Notified Body may suspend the CE Certificate Valid if they failed to submit the Clinical Evaluation Report (CER) within the timeline allocated.

All classes of Medical devices should submit Clinical Evaluation Report (CER) to Notified Body.

Clinical Evaluation Report (CER) review is a part of Technical Documentation ( Technical File / Design Dossier).

Clinical risks and residual risk from risk management should be considered for clinical evaluation to prove the safety and similarly any new risk or adverse effect is obtained in clinical evaluation it should be reflected in risk management considering the design or material change if required. They are updated regularly to prove the continuing clinical safety and performance of the device or for the need of modification /rejection of device from the market based on the adverse event or new risk observed.

External Clinical Experts are clinical professionalsí expertise in the subject device, choose and trained by Notified body (NB) for the assessment of Clinical Evaluation and provide advices to NB with respect to the regulations, guidance, common specifications and harmonized standards.