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In-Vitro Diagnostic Medical Device Regulation

It would seem like the new IVD Regulation (IVDR) has been behind the scenes, overshadowed by the Medical Device Regulation (MDR). The IVDR brings with it a totally new classification system, which resembles that of medical devices. Previously, IVDs were classified as either general, self-testing, list A or list B devices. In contrast, with this old system, IVDs will now be classified as D, C, B, A, or other, in descending order with respect to the risk posed by the device.

As a snippet of the changes being made in this Regulation, all self-testing IVDs will fall under class C, except for those devices used to detect pregnancy, test for fertility, determine cholesterol levels, and devices which are used for the detection of glucose, erythrocytes, leucocytes, and bacteria in urine, which are classified as class B.

To determine the classification of a device, one must first consult the classification rules (of which there are seven) highlighted in Annex VIII of the new Regulation. Every manufacturer currently following the IVDD should definitely have a look at these new rules, as we are aware that many devices will need to be “up-classed”, and therefore may require Notified Body involvement. If you are an IVD manufacturer and are concerned about what changes the new Regulation may mean to you, please do not hesitate to get in contact with us. We would be able to propose a classification with respect to the IVDR, and also establish which conformity route should be taken.

The commission is currently focussing on establishing both the Medical Device Coordination Group (MDCG) and the EU Reference Laboratories (EURL). The latter are to be established 18 months before the Date of Application (not 6 months as previously thought). Class D devices will be subject to a control by EURLs and may also be subject to a scrutiny mechanism by an expert group.

The MDCG is a proposed group that will investigate assessments of high-risk devices made by Notified Bodies. The group shall be formed of national representatives, and will carry out their investigations prior to the product being placed on the market.

There is also considerable work being done with respect to companion diagnostics. Currently, there’s a lot of focus on molecular profiling, however it is thought that other technologies may also play a vital role: Immunohistochemistry, traditional immunoassays, protein profiling using microarrays, and mass spectrometry. Furthermore, there is a need to review certain elements of companion diagnostic devices, in particular specification.

With Task Groups still looking into vigilance, establishing expert panels and laboratories, it seems like the Regulation is going to be based on rocky foundations as the details of these are still to be determined. It may be that a classification guidance of some sort will be required, since no doubt the new classification system will bring out some borderline devices which are hard to place in one class. We now all await the end of May for the official publication in the EU Official Journal, and watch how all this unfolds.

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