With the IVDR, the EU has issued a 157-page regulation which supersedes the IVD-Regulation (98/79/EC). The number of articles increased almost fivefold from 24 to 113.
In this article, you will learn which requirements were amended by IVDR, which requirements remained the same and how to get ready for the new regulation.
Since 25 May 2017, the EU regulations, MDR and IVDR are in effect.
Here, you can find the final version of the IVDR in German as a HTML-file, as a HTML-file (with links) and as a PDF and in English as a HTML-file and as a PDF.
Click on this link to download the free Starter Kit providing you with an overview of the regulatory landscape and illustrating the 6 steps to your medical device's "approval".
The IVDR feels responsible for the entire EU in-vitro diagnostics market: from development to market surveillance to usage. Hence, it is equally applicable to manufacturers, importers, users, notified bodies and national authorities.
In particular, the IVDR lays down the conditions ("essential requirements") to be fulfilled by in-vitro diagnostic products.
The regulation is divided into 10 chapters and 14 annexes. Download image as PDF.
The IVDR still knows "essential requirements". However, they are now denoted "general safety and performance requirements". As pursuant to IVDD, manufacturers must provide evidence for their compliance with those requirements as part of conformity assessment procedures.
Furthermore, there are still classes in which products are classified. Conditional to the class, manufacturers may choose the conformity assessment procedure.
Likewise, the IVDR did not change that notified bodies are to be involved in conformity assessment procedures - except for uncritical devices - and that conformity has to be indicated with a CE label.
Even though the IVDR has maintained many concepts such as conformity assessment procedures, notified bodies' being involved and the essential requirements, some partly significant modifications have been made.
IVDR's Annex VIII now defines four classes In lieu of the previous lists A and B.
IVDR even divides in-vitro diagnostic products into further categories:
The number of possible conformity assessment procedures has been reduced. Basically, the IVDR only distinguishes three procedures:
Just as for companion diagnostics, IVDR stipulates specific requirements for devices intended for near-patient or self-testing.
If applicable, reference laboratory and expert panels shall get involved when assessing class D devices.
Manufacturers may continue to comply with harmonised standards. Now, the EU Commissions reserves the right to adopt so-called "common specifications" with which manufacturers must comply.
The Commission grants itself considerable rights. It may define requirements at its own discrection with virtually no involvement of the parliament.
As required for other medical devices, manufacturers are onyl obliged to clearly mark their devices using a UDI and to store the information in Eudamed.
Read more articles on the UDI and Eudamed here.
Each (!) manufacturer of an IVD must have a quality management system, irrespectible of the conformity assessment procedure. However, the IVDR requires a certification by a notifed body for conformity assesment procedures pursuant to Annex IX and XI.
The requirements for the quality management are comprehensive, though. It must comprise:
If you have described and implemented all of those procedures, you can also obtain certification according to ISO 13485:2016.
IVDR stipulates that notified bodies shall conduct an unannounced audit at least every five years. All manufacturers with a certified QM system are affected.
Manufacturers are obligated to describe what the device is supposed to do and how they ensure the actual performance of the device without unacceptable risks very precisely. Performance date comprises, for example, "analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off" etc.
Requirements for performance assessment are correspondingly extensive.
IVDD put the issue of software in second place. For example, no requirements for the software life-cycle were defined. IVDR changes this:
All in all, those requirements do not come as a surprise. Rather, they reflect what the IEC 62304 and, in part, the ISO 13485 specify more precisely.
Just as ISO 13485:2016, the IVDR attaches more importance to sufficient qualification of staff. The "Compliance Officer" is a new, explicitly required role.
Among the additionally notable amendments and tightenings by die IVDR are:
Manufacturers are recommended to promptly start with their homework:
The IVDR entered into force on May 25, 2017 and is scheduled to become mandatory on May 26, 2022. This would make a high proportion of the declarations of conformity issued under the IVDD invalid from May 2022.
However, on October 14, 2021, the EU Commission published a proposal that could give manufacturers of IVD medical devices more time.
Under the Commission's proposal, the date the IVDR will start to apply will not change from May 26, 2022. However, manufacturers who have placed their IVD medical devices on the market in compliance with the IVDD will be given more time to demonstrate compliance with the IVDR.
As with the MDR, there will be transitional periods. These periods do not just apply for IVDmedical devices for which a certificate was issued by a notified body under the IVDD but also for devices classified as “other IVD medical devices” that do not require the involvement of a notified body under the Directive.
The new transitional periods for “other IVDs” would depend on the risk class according to the IVDR.
Please note that this is currently only a (non-binding) proposal from the European Commission!
For devices manufactured and used only within a health institution, the proposal also provides for some more leeway. The main purpose of this is to relieve the burden on health institutions, such as laboratories, that have been hit hard by the coronavirus pandemic.
Article 5(5) of the IVDR provides special regulations for such devices. The deadline for the implementation of subsections (b) and (c), and (e) through (i), is now May 26, 2024. For d), the deadline is now May 26, 2028.
“the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market”
Article 5(5)(a) is excluded from the extended deadlines. Therefore, from May 26, 2022, all lab developed tests in the EU must meet the general safety and performance requirements set out in Annex I and may not be provided to another legally independent facility – legal requirements that are already established in Germany in the Medizinproduktegesetz (MPG).
However, the extensions proposed by the Commission would NOT apply to two device groups:
For non-sterile class A devices, manufacturers will have to provide proof of conformity according to the IVDR before May 26, 2022 in all cases.
Similarly, the proposed extensions do not apply for “new” in vitro diagnostic medical devices. The Commission considers in vitro diagnostic medical devices whose conformity has not been certified under the IVDD as “new” devices.
For these devices, manufacturers will also have to demonstrate conformity according to the IVDR before May 26, 2022 in all cases.
The Commission has justified its proposal primarily with reference to the impacts of the coronavirus pandemic that is tying up a lot of resources, making it almost impossible to implement necessary measures quickly.
However, the current impact of the MDR on the medtech market is also likely to play a role. The aim is to avoid the kind of device culling caused by the MDR with in vitro diagnostic medical devices. Various actors have been sounding the alarm for months already.
The Commission also recognizes the urgency of the situation in its proposal:
IVDR has considerably raised the bar. The regulation's defined own objective is to enable small, innovate companies market access with finite effort. This target was clearly missed. The set of rules became too extensive for this to be reached. Consequently, a "Compliance Officer" became nearly inevitable for IVD manufactuerers.
If the IVDR results in higher safety of patients, users and third party is extremely doubtful. It is relatively certain that the IVDR has lead to more bureaucracy and less innovation.