One of the obligations for manufacturers of medical devices is that they shall ensure that the medical devices have been designed and manufactured in accordance with the applicable legislation. In order to determine whether medical devices are manufactured in accordance with the requirements set out in the applicable legislation, tests must be carried out.
The type of testing that your medical device requires is fully dependent on the specifications and intended use of the medical device. For example, tests with regard to the biocompatibility could be required for an invasive medical device, where electrical safety testing could be required for active medical devices.
It is also possible to perform tests in accordance with a standard that is harmonized under the applicable legislation. For example, when you are the manufacturer of prosthetics, it is recommendable to test the prostheses in accordance with the EN ISO 10328:2016 standard.
The test results shall be part of the Technical Documentation of your medical device.
Are you bringing a medical device onto the European market? It is a legal obligation of the manufacturer to ensure that the medical devices have been designed and manufactured in accordance with the applicable legislation. CE Medical can assist you with determining which tests are applicable for your product as well as conducting the applicable tests.