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Medaval’s Star-Rating Criteria to Assess the Accuracy of a Medical Device

Independent scientific clinical validationCurrent standard protocolPublished within last 10 yearsMore than one validationCertified by Medaval
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Cannot be Certified
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No Star
No Symbol
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Details

Independent scientific clinical validation Medaval accepts these four methods of completing an Independent Scientific Clinical Validation of a medical device. A primary validation must be in a general sample from the population for which the device is intended. Validations in special groups only cannot be considered as applicable to a general population.
Medaval Bullet Publication in a peer-reviewed scientific journal.
The vast majority of these are listed on PubMed. Validations must have been completed according to a standard protocol.
Medaval Bullet Equivalence according to Medical Device Regulations (MDR) standards.
These new standards are due to become mandatory within the EU in May 2020.
Medaval Bullet Published report by a recognised organisation.
Some devices are tested by organisations recognised by government or professional bodies. The reports must contain the information to enable a full assessment according to the relevant protocol.
Medaval Bullet Medaval assessment.
Medaval assesses strict compliance of a study according to protocol requirements, produces a report and has the report peer-reviewed before publication.
Current standard protocol In order to ensure the highest scientific standards, validations should be carried out according to the most recent version of a standard protocol.
Medaval Bullet When a new version of a protocol is introduced, the previous version remains "current" for a set transition period. For Medaval certification to be considered, a current standard protocol must have been used.
Published within last 10 years In order to ensure that the validation is reasonably recent, the year of the most recent validation publication must be within 10 years from the current year.
Medaval Bullet For Medaval certification to be considered, the validation must be within this period. Devices are reassessed each January. Those where validations exceeded 10 years or where protocols have been superseded, will lose stars accordingly.
More than one validation A second validation increases greatly confidence in the reliability of the results.
Medaval Bullet Apart from the primary validation, subsequent validations can be in specific groups (such as children, the elderly, pregnancy etc.) or circumstances (such has during exercise, at high altitude etc.).
Certified by Medaval The validation is scrutinised by Medaval to ensure it was carried out correctly.
Medaval Bullet Manufacturers are invited to submit validations for comparison against a checklist, drawn up by experts, to ensure that there are no protocol violations.
Medaval Bullet Where a validation, particularly in a specific group or circumstances requires modofication, this must be supported by appriopriate scientific references.
Medaval Bullet Equivalences must comply with MDR regulations. Devices are compared using a checklist drawn up by experts, to ensure that all core technical, clinical and biological aspects are the same.