Clinical Investigation

MDD 93/42/EEC (Medical Device Directive), amended by the 2007/47/EC,  requires clinical data and an evaluation of that data to ensure the  safety of the medical device. Clinical data is collected or generated  from the clinical use of the device and observing the performance of  this device and its safety. The following activities allow for obtaining  this data:

  • Published data on clinical experience with the device or equivalent
  • Clinical investigation
  • Clinical investigation with similar device
  • Combination of the above

The  medical devices must go through clinical evaluation which is the  process of assessing clinical data and making sure that the data is in  conformity with the harmonized standards and essential requirements that  have been established by the European Union. This clinical evaluation  proves that the device is safe and performs according to its intended  purpose established by the manufacturer.


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

Option One:  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 essential requirements

Option Two: A critical evaluation of results of all clinical investigations made

Option Three: Critical evaluation of data of the combined clinical data provided by literature and clinical investigation.

When  a clinical evaluation is not 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. Clinical evaluation also is focused on  those elements of safety and/ or performance that could not be based on  laboratory testing. Medical Device Directive Annex VIII requires that  all clinical testing has been performed properly.


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.

Manufacturer is responsible for the:

  • Design of the study
  • Designation of principal investigator
  • Application with ethical committee
  • The non-EU manufacturer may choose to appoint an Authorized Representative to complete the notification of the clinical investigation to the relevant EU Member State competent authority
  • 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
  • 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 Community
  • 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.


Role of the Competent Authority

Approval to begin process of investigation

  • Some countries require 60 days
  • Other countries allowed to begin right upon submission of request

There must also be a registration in the European Databank.


Role of the European Notified Body

Investigation must be reviewed by the Notified Body who has such authority.

  • Assessment of clinical safety and performance
  • Conclusion with justification

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