For the Active Implantable Devices Directive and the ‘General’ Medical Devices Directive, the manufacturer is required to document confirmation of conformity with the requirements concerning the device’s clinical characteristics and performance under normal conditions of use, and an evaluation of any undesirable side-effects, based on clinical data.
Whilst it may be possible to obtain this information by means of a review of available scientific data, for higher risk devices and devices based on new technology, formal clinical investigations may be required.
GEMAR can help you identify whether formal clinical investigations will be necessary and, if so, assist in their planning, management and monitoring. Click here to access the Clinical Studies section of our website, or contact us for further information.
If sufficient clinical data is available from published and unpublished sources, then a clinical evaluation file will need to be developed to demonstrate that the clinical benefits of the device outweigh any associated risks. An updated MEDDEV guidance document was published in December 2009, which provides essential guidance for manufacturers writing clinical evaluation reports. GEMAR can assist manufacturers develop these reports for both new and existing devices.