IVDR Verification of class D IVDs
This content has guidance for establishing the activities of Notified Bodies for the verification process of class D IVD devices. According to the law on in vitro diagnostic Medical Devices (IVDR), Regulation (European) 2017/746, class D devices need to demonstrate their conformity assessment via the involvement of a notified body. In those terms, manufacturers of class D IVDs should forward to notified bodies a report of tests performed on each batch of devices and make available samples or batches of devices to the notified body. The notified body involved in the conformity assessment of class D IVDs should request one of the European reference laboratories (EURLs), if designated via the European commission, to carry out batch testing on those devices. Only upon verification of conformity, the manufacturer can proceed to place class D IVDs on the market.
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IVDR – Verification of class D IVDs by notified bodies
The main points provided by using the guidance include Notified Body process, contractual arrangements, and overall performance of checking out, indexed right here below:
Notified body procedures
Appointed by means of the manufacturer, the Notified Body performs conformity assessment activities of manufactured class D devices. The agreement between the notified body and the manufacturer should include all necessary preparations related to the performance of the exams, inclusive of a test plan, the transportation of the samples, and all records related to the batches, e.g., batch release quality control results, and conclusions of the verification of manufactured batches. Furthermore, the manufacturer commits to inform the Notified Body about any changes in the devices that affect the verification of the batches as well as to communicate any relevant scientific, technical, or medical information that comes to his knowledge.
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Moreover, the Notified Body has to establish documented processes for:
- The verification processes
- The establishment of a test plan including all relevant and critical parameters which have to be examined for the device
- The arrangements with the manufacturer specifying where and when the tests will be performed
EURL testing: arrangements and procedure
Assuming that the device desires to undergo further checks performed by an EURL, the notified body needs to make certain arrangements for such testing. Similarly, a written contract between them should define all necessary processes for the trying out. This includes, for example, the check plan, the transportation of the samples, batch information, and predicted time-frame for trying out (commonly 30 days). Moreover, the notified body commits to tell the EURL approximately any applicable scientific, technical, or clinical observations that come to his attention as well as to speak about all important facts from the conformity check.
Frequency of EURL trying out
The notified body should send samples of batches to the EURL, specifying the products made to be had to the EURL and the frequency of checking out. The frequency of testing ought to be based on the frequency of device failure and the relative risk/impact by the intended use. Thus, batches that must be tested more frequently are batches of devices with higher failure, devices with presence of or exposure to transmissible agents, and batches of blood grouping devices. The notified body can, together with the EURL, reduce the frequency of testing upon a demonstrated history of appropriate overall performance.
Number of batches to test
For first-line assays and devices intended for diagnosis, every single batch must be tested. For other devices, the notified body determines the number of batches to be tested. To do so, the notified body considers the batch-testing regime defined by the manufacturer, the scientific opinion of the EURL, and possibly, the additional opinions of further experts.
Reference link – IVDR: Verification of class D IVDs by notified bodies · MDlaw – Information platform on European medical device regulations
