During preparation of the technical file, the manufacturer should perform all the required trials of the medical device. The aim of the trials is to confirm compliance with the requirements of MDR 2017/745, IVDR 2017/746 and the standard applicable for the devices.
The trials can be nominally divided into the following groups:
In the technical file, the trial results are given in the section Product verification and validation.
Technical trial is testing performed to determine compliance of the characteristics (features) of the device with the regulation documentation, technical and operational documentation of the manufacturer. It includes determination of overall dimensions, weight, hardness, testing of functional characteristics, check of resistance against climatic and mechanical influence, confirmation of the declared service period, etc.
Testing for bio-compatibility confirm safety of the materials used for production of the medical device at contacting (directly or indirectly) the human body.
Pre-clinical trial is the animal studies with aim to get information on use of the medical device for a living organism before to use it for a human. According to the features of medical devices, preliminary animal study is not applicable for all the devices.
Clinical trial is testing with use of a human as a subject to testing. Such a trial is not always performed. CE certification requires clinical evidence confirming clinical efficiency and safety of the medical device.
For the devices with low risk class, such an information can be received from scientific literature, clinical experience of use of a similar device. For the implantable devices and the devices of the III class, clinical trials with a human as a subject are mandatory (except for some clearly decided cases).
In most cases, you can get the CE certificate without performing clinical trials. However, the manufacturer anyway needs to prepare the Clinical evaluation report that includes analysis of all the available clinical evidence.
Specific trials include those that are required for specific types of devices, for example, testing for electromagnetic compatibility.