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Clinical Evaluation and Investigation

The MDR(article 61 and Annex XIV) reinforces clinical data and evaluation process. Manufacturers shall provide sound clinical data and evaluation to confirm the device conformity with essential health and safety requirements. The clinical evaluation proves that the device is safe and performs according to its intended purpose, assesses the undesirable side effects, as well as the acceptability of the benefit-risk ratio. Manufacturers shall plan, conduct and document a clinical evaluation in accordance with Article 61 and Part A of Annex XIV. 

The clinical evaluation must follow a certain procedure based on either:

OPTION 1

A critical evaluation of the relevant scientific literature currently available evaluating the design characteristics, safety, and performance of the device all based on its intended use where:
there is demonstration of equivalence of the device to the device to which the data relates and the data adequately demonstrates compliance with the relevant safety and performance requirements

OPTION 2

A critical evaluation of results of all clinical investigations made with a consideration of alternative treatment options currently available.

OPTION 3

A consideration of all current alternative treatments

When a clinical data is not deemed appropriate, there must be adequate justification based on risk management output and under consideration of the specifics of the device/body interaction, the performances intended and claims of the manufacturer. In that case non-clinical testing methods alone, including performance evaluation, bench testing and pre- clinical evaluation, need to be appropriate.

The clinical evaluation shall be updated throughout the life cycle of the device with clinical data obtained from the implementation of the manufacturer’s PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.

For class III and implantable devices, a PMCF evaluation report shall be updated yearly, and a summary of the safety and clinical performance shall be uploaded to the EUDAMED and updated yearly.

GEMARMED conducts scientific literature searches in line with MDR, Annex XIV, Part A and the latest MEDDEV guidance 2.7/1 revision 4, Annex A4 and A5, which forms the basis for preparing and updating clinical evaluations. In terms of clinical evaluations, we offer specific services designed to meet the individual needs of our customers by either providing support during the evaluation process or preparing a clinical evaluation report or its update.

YOUR BENEFITS

  • Equipped with recent and individually customized literature, you can get an idea of your device’s ranking on the global market and the key factors relevant for the medical practice.
  • Our up-to-date clinical evaluation helps you to save time and speed up the conformity assessment procedure with your notified body.
  • With literature evidence prepared by our experts, you can save costs by avoiding unnecessary clinical investigations or PMCF studies.

Post Market Clinical Follow-Up (PMCF)

Studies or Plans

Within the new, stricter European Medical Device Regulation (EU-MDR), which will now come into force on the 26th May 2021, there is more emphasis on a life-cycle approach to safety, backed up by clinical data and post-market monitoring. Post Market Clinical Follow-up (PMCF) falls within the Post Market Surveillance (PMS) plan and will require manufacturers to not only reactively assess the safety and performance of their devices, but they will also need to pro-actively assess and record this data throughout the product’s lifecycle.

Although randomised clinical trials and registries provide higher levels of evidence, they may not be possible for certain devices. On the other hand, end-user surveys require less work, money and time.

GEMARMED has developed a best-practice approach for PMCF Studies or PMCF Plans, approved by EU regulators and compliant with GDPR regulations, to pro-actively assess the experience of customers with your medical device, for inclusion in your PMCF submission. 

We have already completed more than 100 bespoke PMCF surveys for some of the leading medical device manufacturers.

GEMARMED can help support you with the design, implementation, data collection and reporting of your PMCF surveys. Make sure that you have everything in place to be compliant with the EU-MDR, today. 

Clinical investigation for class III and implantable devices

In the case of implantable devices and class III devices, clinical investigations shall always be performed except if:

  • the already marketed device has been modified by the same manufacturer, and
  • the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, and this demonstration has been endorsed by the notified body, and
  • the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements,
  • In addition, NO obligation of clinical investigation for class III and implantable devices in case a manufacturer demonstrates that its device is equivalent to an already marketed device, this demonstration has been endorsed by the notified body and the following conditions are fulfilled: the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis, and
  • the original clinical evaluation has been performed in compliance with the requirements of the MDR, providing clear evidence to the Notified Body.

In addition, NO obligation of clinical investigation for class III and implantable devices:

  • If the devices have been lawfully placed on the market under the former directives and for which the clinical evaluation is based on sufficient clinical data and comply with Common specifications where available

NO obligation of clinical investigation for devices such as: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data.

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Manufacturer’s responsibility

Clinical investigation is the systematic study or investigation of safety and performance of a device being used by human beings in accordance with the device’s normal use. Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsors’ obligations pursuant to this Regulation.

Manufacturer/sponsor is responsible for the:

  • Design of the study
  • Designation of principal investigator
  • Insurance
  • Application with ethical committee
  • The non-EU manufacturer/sponsor may choose to appoint the Authorized Representative to complete the authorization of clinical investigation to EUDAMED.
  • Incident Reporting-in the event of an incident during the clinical investigation, the reporting as such will need to be determined and performed by the appointed Authorized Representative through the EUDAMED database
  • Documentation available-the clinical investigation data (reports) should be incorporated in the technical documentation that has to be kept available by the manufacturer of his appointed European Authorized Representative established within the Union.
  • Sponsor (authorized representative) shall notify the competent authorities of the ending of the clinical investigation, and submit a report.

Clinical Investigation plan:

  • Informed consent and ethical consideration
  • Clear measurable objectives
  • Criteria to stop the trial
  • Statistical power
  • Patient population equivalent to EU

The clinical evaluation and its documentation must continually be updated by its post-market surveillance information. If this post-market surveillance is not needed for some reason in following up on the medical device, an acceptable justification must be given and documented. For high risk devices, there must be a clinical follow-up report given with the final report

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