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 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.
a) 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
b) A critical evaluation of results of all clinical investigations made
c) 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.
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
Clinical Investigation plan:
– 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