A clinical evaluation according to MEDDEV 2.7.1 is performed in 5 steps.
Clinical evaluation: Preparation or step 0
Preparation or Step 0 is the preparation of the clinical evaluation plan based on the Essential Safety and Performance Requirements to be addressed.
This plan includes the following points:
a) Product description
b) Design features, intended use, indications, contraindications and target populations requiring special attention.
c) Data and results of the risk assessment.
d) Präklinische Daten aus Verifizierungs- und Validierungsschritten.
e) State of the art in the relevant medical field, standards and guidelines. Information related to the medical aspects, its natural history, benchmark-devices, other devices and medical alternatives.
f) Data sources and type of data. Relevant data may be generated by the manufacturer and/or drawn from the scientific literature.
g) Information for the assessment of equivalence, if equivalence can potentially be claimed.
h) Clinically relevant product changes (for devices already CE marked).
i) New clinical risks (for devices already CE marked).
j) Aspects from market surveillance to be regularly updated in the clinical evaluation report (for devices already CE marked).
k) Who works in this team and with what qualifications.
Clinical evaluation: Step 1
In step 1, the product under consideration, its clinical and technical status are described and the aspects to be considered and the necessary data to be compiled are defined. Data is collected from various sources.
These include
a) Product description and product accompanying information,
b) Data from the company's own risk assessment
c) Data from our own market surveillance and product monitoring
d) Vigilance data (own and from the databases at BfArM, FDA, swissmedic etc.)
e) Preclinical data from verification and validation measures
f) Own data from clinical trials
g) Clinical data from published studies in relevant databases (ATTENTION: equivalence discussion)
Clinical evaluation: Step 2
In step 2, the available data are assessed and their suitability for this clinical evaluation is determined.
During the assessment, appropriate rating scales should be developed so that the assessment is comprehensible to third parties. You can use a numerical system, e.g. assigning points from 1 to 10 for author qualification, evidence, product relevance, etc. or you can also assign "-" and +++". How you do this is up to you. Check here whether all clinical aspects can be substantiated with data. Look out for gaps in the information and close the gaps with suitable data.
Clinical evaluation: Step 3
Step 3 involves a critical appraisal of the data. Positive and negative data are taken into account. Recommendations for measures and further data collection are made.
At this point, you should make sure that you really consider all the previously collected and evaluated data and note why the data supports your performance claims or concerns possible residual risks. If you use clinical data from databases, remember to show that the data is transferable to your product. Carry out an equivalence discussion and compare the technical, biological and clinical characteristics of your product with the product from the clinical trial.
Clinical evaluation: Step 4
In the final step 4, the above steps are summarised as a result and approved with the signatures of the parties involved.
All aspects should be listed again here, i.e. who prepared this report, for what and how. If the state of the art is adhered to, preclinical data, vigilance data etc. are available and the clinical suitability can be confirmed. Discarded data are not taken into account or recorded.
Our conclusion
If you can substantiate all clinical aspects with suitable data from the literature, it is not necessary to conduct your own clinical trials. However, please note that you should critically discuss any information gaps and close them in an appropriate manner. Information gaps can be filled with laboratory tests or clinical trials. Negative information must also not be withheld. Rather, this must be refuted in a verifiable manner.
(1 Rating(s), average: 5.00 out of 5)
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