Medaval is committed to working with manufacturers to help them ensure that their accurate devices are accredited according to a harmonised protocol according to MDR (EU) 2017/745 requirements. At present we only provide this service for blood pressure monitors and blood glucose meters but also assess validations of pulse oximeters.
Please feel free to get in touch with us regarding any of Medaval’s services by clicking here or on the email above to use your own email service. We will respond to your query as soon as possible.
Medaval provides validation services according to AAMI/ANSI/ISO 81060-2:2019 (aka BS EN ISO 81060-2:2019, ISO/TC 121/SC 3. ISO 81060-2:2018) for a general population. This protocol is required for compliance with MDR (EU) 2017/745.
Medaval provides equivalence for blood pressure monitors and blood glucose meters according to MEDDEV 2.7/1 rev 4. Device equivalence is regarded by Medaval as a scientific validation study that requires publication in a scientific journal. MEDDEV 2.7/1 rev 4 requires that not only core measurement technology is proven to be identical but that differences are also identified. Thus, as our protocol also provides this comparative aspect, we refer to our service as “comparative-equivalence”. Devices proven to be equivalent form a device family and any validation of the technology applies to all members of that family automatically. This is, therefore, an efficient and cost-effective method of ensuring that devices using that technology, with different supplementary features or accessories, are proven to be validated. It is also a very cost-effective method for validating OEM and OBL devices.
Where a device has been validated independently, Medaval will scrutinise a published paper or a report submitted to a notified body to ensure that all protocol requirements are met. It can also analyse data from an independent study.
Medaval provides an audit service whereby a manufacturer can provide details of all its devices, their measurement technologies and validations and Medaval will indicate how they can be brought into compliance efficiently and at minimal cost.
Medaval’s services are carried out in strict compliance of MDR (EU) 2017/745 requirements. These requirements also satisfy requirements of bodies outside the EU.
Medaval submits papers for publication in peer-reviewed scientific journals for validation studies and equivalences as part of those respective services.
Notified Body Reports
Medaval provides reports for presentation to notified bodies for validation studies and equivalences as part of those respective services. It can also provide such reports as a separate service for data provided to it from independent sources.
Medaval provides manufacturers with certificates of accuracy. Claims of “clinical accuracy” or “declarations of equivalence” are essentially meaningless without independent scientific proof, not only of the study but also that the protocol was followed precisely and complies with MDR requirements. Where validation in certain medical conditions or circumstances requires deviations from a protocol proof must be provided that the alterations performed are both necessary and reflect the diversity of that population.
Manufactures can use the emblem indicating the Medaval star-rating proof of accuracy awarded to a device freely for that device, as proof accuracy. It cannot be used unless it also appears on the Medaval Website.