safety and effectiveness of medical devices
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The essentials requeriments of medical devices what kind of trial include?
Is is neccessary that the trials of safety and effectiveness of medical devices should be at GLP Laboratories??
How could justified and explain the safety and effectiveness of the medical device trial?
Thank you very much in advance.
Medical Device Comm
The testing of the safety and effectiveness of medical devices should be done in a GLP accredited facility, or a facility which adheres to ISO 17025.
Refer to ISO 10993-1 for biocompatibility testing (safety), and for effectiveness (=efficiency/evaluation) refer to MEDDEV 2.7.1, 2.7.2, 2.7.3 and 2.7.4.
Essential Requirement 6a refers to Annex X which provides additional requirements for clinical data, including when a clinical investigation is necessary. See also MEDDEV 2.7.1 for further guidance. If a clinical investigation is required the requirements of ISO 14155-1 should be applied.
Medical updates are necessary for a number of reasons. A healthcare setting has to keep giving medical updates to the families of patients that it is treating. A medical update becomes very important for the media when an important person is undergoing treatment. Medical updates are also given out on social media whenever something significant is noticed or discovered that could be of use to society at large.
More Info : https://www.mentorhealth.com/control/rules-and-regulations-medical-device-update
The safety and effectiveness of medical devices are not so closely regulated compared to drugs as a different law under-sees this. There needs to be more laws to control the production of such devices. At least the devices to be placed inside the body, like pacemakers, needs more rules and regulation before legalising the usage of it by medical institutions.