The Medical Device Coordination Group (MDCG) has published a Guidance establishing the activities of notified bodies in the verification process of class D IVD devices.
According to the Regulation on in vitro diagnostic medical devices (IVDR), Regulation (EU) 2017/746, class D devices need to demonstrate their conformity assessment through the involvement of a notified body. In these terms, manufacturers of class D IVDs should forward to notified bodies reports of tests carried out 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 EU reference laboratories (EURLs), if designated by 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.
The main points presented by the Guidance include notified body procedures, contractual arrangements, and performance of testing, listed here below:
Notified Body Procedures
Appointed by 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 arrangements related to the performance of the tests, such as a test plan, the transportation of the samples, and all information 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 clinical information that comes to his knowledge.
Moreover, the notified body should establish documented procedures for:
- The verification process
- The establishment of a test plan including all relevant and critical parameters which need to be tested 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 needs to undergo further tests performed by an EURL, the notified body should make arrangements for such testing. Similarly, the written contract between the should define all necessary procedures for the testing. This includes, for example, the test plan, the transportation of the samples, batch information, and estimated timeframe for testing (usually 30 days). Additionally, the notified body commits to inform the EURL about any relevant scientific, technical, or clinical observations that come to his attention as well as to communicate all necessary information from the conformity test.
Frequency of EURL testing
The notified body must send samples of batches to the EURL, specifying the products made available to the EURL and the frequency of testing. The frequency of testing should be based on the frequency of device failure and the relative risk/impact on 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 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.
You can find the full text of the MDCG Guidance in our dedicated Library – Notified Body.