This page is no longer maintained. On 26 May 2022 the EUIVDR entered into application and the IVDD was repealed.
The conformity assessment concept in the new European Union In Vitro Diagnostics Regulation (IVDR) is essentially unchanged from the current In Vitro Diagnostics Directive (IVDD). The IVDD’s conformity assessment Article has really just been renumbered, Article 9 of the current IVDD will be replaced by Article 48 of the new EU IVDR. Likewise, the conformity assessment Annexes have also been renumbered and renamed; Annexes III to VII of the current IVDD, are replaced by Annexes IX to XI of the new EU IVDR. But apart from that, the requirement for Manufacturers to conduct a conformity assessment before placing their IVD device on the market, and in the case of higher risk IVDs to involve a Notified Body, is unchanged.
Class D IVDs (comparable to the former Annex II List A IVDs): The current IVDD’s Annex IV “full quality assurance” route is replaced by the new EU IVDR’s Annex IX “conformity assessment based on quality management system assurance and assessment of the technical documentation”.
There are still alternatives for those Manufacturers who choose not to follow the full quality management system approach. The current IVDD alternative for Annex II list A devices is Annex VII “EC type-examination”, combined with Annex V “production quality assurance”. This is replaced by the new EU IVDR’s Annex X “conformity assessment based on type examination”, combined with the new Annex XI “conformity assessment based on production quality assurance”. However, the requirements for this class of IVDs do not end there. Additional requirements for this class of IVD include verification testing by an EU reference laboratory against EU common specifications. Or in the case of devices for self-testing or near-patient testing, there are additional requirements for the assessment of technical documentation.
Class C IVDs (comparable to the former Annex II List B IVDs): As under the current IVDD, Manufacturers of this class of IVDs have the option of following the same conformity assessment route as for the higher class IVDs described above. Namely, the new EU IVDR’s Annex IX. The difference being that the Notified Body is only required to assess the technical documentation of at least one representative device of each generic device group (still to be formally defined) of IVDs produced by the Manufacturer. Again, as with the current IVDD, there are alternative routes for Manufacturers of this class of devices who choose not to follow the full quality management system approach. These alternatives are the same as those for Class D devices described above. Also as stated above, for devices for self-testing or near-patient testing and for companion diagnostics, there are additional requirements for the assessment of technical documentation. Additionally, in the specific case of companion diagnostics, the Notified Body must also obtain a scientific opinion from a medicines Authority.
However, there is one fewer alternative available to Manufacturers of this class of IVDs compared to the IVDD. There is no equivalent to the IVDD’s Annex VI “EC Verification” or Product Examination by NB. Manufacturers currently following this route will have to choose an alternative route.
Class B IVDs (formerly only devices for self-testing but now including the majority of what were previously referred to as “other IVDs”): As part of what is possibly the biggest change introduced by the new EU IVDR in comparison to the current IVDD, Manufacturers of this class of IVDs will only have one option, following the new Annex IX. But with the Notified Body only assessing a sample of the technical documentation for each category (still to be formally defined) of IVDs produced by the Manufacturer.
Class A IVDs (comparable to what were previously referred to as “other IVDs” but under the IVDR this will actually be a very small number of IVDs): The conformity assessment approach is essentially the same as in the current IVD Annex III “EC declaration of Conformity”, generally referred to as self-declaration. Namely, the Manufacturer prepares the new EU Declaration of Conformity (new Article 17), having of course first fulfilled the general obligations of all Manufacturers (new Article 10). The involvement of a Notified Body being limited to sterile Class A devices only.