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Clinical Evaluation - Frequently Asked Questions

MDR and MDD CE Marking of Medical Device in Europe, a Clinical Evaluation is a MUST.

The 2007 amendment to the European Medical Device Directive comes into force in March 2010 and Medical Device Regulation (MDR) release on 2016 requires a CER as per MEDDEV 2.7/1 Revision 4 be conducted as part of the process of CE Certification and maintenance of the CE Certificate Validity. Since Notified Bodies (NB) will review the CONCLUSION of the Evaluation, it is important that the evaluation is conducted correctly and robustly. The clinical evaluation determines whether a new clinical investigation is required for the device in question..

Identification, appraisal, analysis and assessment of literature - What is the average number of articles attached to a report?

    Minimum of 10 - 15 articles discussing Intended use, Contraindication, Warning, Material suitability, Device Safety & Residual Risks.

Is it necessary to attach the full text of the selected article? Does this violate copyright laws?

    Yes, the full text of the selected article is to be attached in the CER documentation. Since, we are not modifying the contend or editing the article, it does not violate copyright law.

Do you think it is important to have an information scientist / Doctor assist in developing the search strategy?

    Yes, expert in the field can do in depth of literature search with relevant key words. Even consultants and medical writers in the field is recommended.

What are keywords or Key phrases? How can I derive that?

    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.

Why canít I simply search on a keyword in google string and see if I like and attach what I get?

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

What is the average length, in number of pages for CER, or what is the range in pages?

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

How CER is related to PMS & PMCF? How important is this in Report?

    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..

How Clinical Evaluation Report is related to Equivalent Device? How important is this in CER?

    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.

How can I get equivalent Device data? If so not avliable in public domain. What is the solution?

    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.

What are the most common deficiencies in reports that a Notified Body can found out in CER?

    (a) Medical Device variants and construction features not covered in the Evaluation.

    (b) Equivalent device data not sufficient or no justification provided

    (c) No data covering state of art and current knowledge and technology

    (d) No enough and robust justification for any deviation from Meddev 2.7.1/ Rev.4 concepts

How good the search obtained from EMBASE? Is MEDLINE, PUBMED or NCBI is enough?

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

Can I have or important to have a statistician appraise each article for statistical validity, or can I do this myself?

    It can be done by the individual who is doing CER.

I have a device already FDA 510k, can I send you the 510k application instead of writing a new Report?

    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.

Can I use videos of medical procedure and argue that my device is safe and effective for the intended use and NO clinical complications?

    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.

How Clinical Evaluation is related to Risk analysis as per EN ISO 14971?

    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.

How Clinical Evaluation and IFU / user manual related?

    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.

Will a Notified Body would ever inform a company that a Clinical Evaluation Report is not adequate, and they need to do a new clinical trial? If so, why?

    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

    (a) where the clinical evidences and clinical data not relevant and accurate to the device in question.

    (b) If the device is new with respect to technology,

    (c) If the device is new with respect to use, material of Construction and application

    (d) No similar device is available in the market

    (e) Multiple recalls on similar device is reported.

What will happen if a company does not update an existing Report during Surveillance audit? Will the device be withdrawn from the market?

    The Notified Body may suspend the CE Certificate Valid if they failed to submit the CER within the timeline allocated.

Reports to be submitted to the Notified Body? or only for class III devices?

    All classes of Medical devices should submit CER to Notified Body.

How long does a Notified Body takes generally to review the CER?

    CER review is a part of Technical Documentation ( Technical File / Design Dossier)

Additional Resources

  • Frequently Asked Question about Clinical Evaluation.
  • Buy Meddev 2.7/1 Rev 4 updated Procedure, Plan and Important templets.
  • Periodic Safety Update Reports (PSUR).
  • Cost of Outsourcing Clinical Evaluation Documentation as per MEDDEV 2.7/1 Rev 4.
  • CER GAP Analayis.
  • More information about Clinical Evaluation.
  • EU MDR CER Checklist.
  • Post Market Clinical Follow Up (PMCF).
  • Post Market Surveillance (PMS).
  • Importance of Annual CER Updates.
  • Cinical Evaluation Blog.
  • Download an usefull artile in PDF about Clinical Evaluation.
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

  • Council Directive 90/385/EEC of 20 June 1990 relating to active implantable medical devices.

  • MEDDEV 2.7/1 revision 4 guide for manufactures and NB’s.

  • List of Harmonized Standards - Official Journal.

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