Medaval Star-Rating Criteria

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.

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.
Equivalence according to Medical Device Regulations (MDR) standards: In order to ensure scientific standards, MDR equivalence regulations are now required by Medaval in order to prove that the measurement technologies in different devices are identical and that validations of that technology must, therefore, apply accordingly. These new standards became mandatory within the EU in May 2021.
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 assessment: Medaval assesses strict compliance of a study according to protocol requirements, produces a report and has the report peer-reviewed before publication.

Standard protocol at validation

In order to ensure the highest scientific standards, validations should be carried out according to the most recent version of a standard protocol.

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.
For certification, protocols recognised as standard at the time of the validation are considered "current".

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.

For Medaval certification to be considered, the validation must be within this period at the time of certification.
Non-certified 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 Those where validations exceeded 10 years or where protocols have been superseded, will lose stars accordingly.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.

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.

Manufacturers are invited to submit validations for comparison against a checklist, drawn up by experts, to ensure that there are no protocol violations.
Certification "locks-in" the prococol and publication to the time of the certification. In other words they cannot be uncertified, unless subsequently recalled.
Four-star certification can be upgraded to five-star if there is a second validation proving accuracy in a general or specific popultion.
Where a validation, particularly in a specific group or circumstances requires modification, this must be supported by appriopriate scientific references.
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.