The New EU IVD Regulation Is Here: Fasten Your Seatbelts, and Get Ready for the Ride
The long-awaited and perhaps feared new EU text that will regulate all in vitro diagnostic products on the EU market has arrived.

Well, it finally arrived. The long-awaited and perhaps feared new EU text that will regulate all in vitro diagnostic products on the EU market is available on the EU website.
The industry was apprehensive about the repercussions of the PIP breast-implant and metal-on-metal prosthesis scandals on the regulations. At one point, there were even rumors that the whole EU legislative system would abandon “new approach” principles in favor of a rigid pharma-like pre-market approval process. Well, nothing of the sort happened; but the devil, as usual, maybe in the details.
On September 26, 2012, the European Commission (EC) released the first drafts of the new EU regulations for medical devices and IVDs.
No, you don’t have to comply starting tomorrow. In fact, the process has just begun: the proposed text has been presented to the EU Parliament and Council of Ministers for review and comments.
These two European bodies are notorious for being quite active and vocal, and we have to be prepared for potentially stricter requirements being proposed, particularly if any new scandals loom on the horizon.
If all goes well, we can expect formal adoption of the regulations in 2014 with a gradual entry into force from 2015 to 2019.
Regulations! Not Directives
Having announced that the entry into effect won’t happen before 2015, I’ve probably lost at least half of my readers. So first let me thank those who are holding fast and still reading…
At first glance, the EC has combined the Active Implantables Directive (90/385/EEC) with the Medical Devices Directive (93/42/EEC). Although this was expected, it is still a relief to see that we still have separate proposed legislation for IVDs, in light of the fundamental differences between these products and medical devices.
The second thing worth mentioning is that the proposed texts are regulations, not directives.
EU member states have interpreted and implemented the current directives in different ways, which led to different levels of patient and public health protection in the European Union and created obstacles within the single market. This explains why the EC was determined, since the beginning, to draft EU regulations, which are laws unto themselves and do not need to be transposed into law within each member state, as is the case for directives.
Socio-Political Drivers
One of the main objectives of the Commission is to ensure greater transparency and traceability, which are perceived as the main shortcomings of the current EU regulatory system.
In the opinion of the EC, greater transparency is needed because patients, healthcare professionals, and other interested parties do not have access to essential information on how medical devices and IVDs are assessed and the clinical evidence that shows them to be safe and effective. This is also why a great part of the Eudamed database will be publicly accessible.
New and stricter traceability requirements are designed to prevent scandals such as those that rocked Europe recently. This is the rationale behind the imposition for all devices to have a Unique Device Identifier (UDI).
In summary, the most significant changes are as follows:
1) Wider and clearer scope.
The proposed IVD Regulation extends to special types of IVDs that have raised concerns among Competent Authorities in the past: genetic tests and companion diagnostics defined respectively as tests for providing information about the predisposition to a medical condition or a disease and tests providing information to predict treatment response or reactions.
For the same reason, and marking a temporary victory for the IVD industry, the text includes within its scope devices that are manufactured and used by a single health institution (i.e., laboratory developed tests or LDTs).
Although only some requirements apply to all of these devices, high-risk LDTs are, rightfully, subject to essentially the same requirements as commercial ones.
More specifically, the proposed EU IVD regulation defines the term “health institution,” and although it still could be more explicit, it thus emphasizes that LDTs offered by companies that are not health institutions are fully subject to the IVD Regulation. This includes many companies, mostly in the United States, that offer tests as a service and as a commercial activity, and which now often believe (or like to believe) that they are not subject to CE marking.
Also part of the “clearer scope,” the EC is placing an emphasis on the introduction of the concept of clinical evidence required for all IVDs. This is based on the fact that although the current IVD directive requires both analytical and clinical assessment of IVDs, it has been largely interpreted by the industry as requiring only a demonstration of analytical performance.
Finally, in addition to the expected specific requirements for medical software, which can be a device in itself, the text puts forth innovative requirements for those defined as economic operators: manufacturers, Authorized Representatives, importers, and distributors. While the first two are a given, the specific addition of importers and distributors within the scope of the regulation will cause repercussions.
Requirements will range from having the importer’s name and address on device labeling to being legally responsible for ensuring that devices are rightfully CE-marked and have a Declaration of Conformity, technical documentation, and so forth. Most important of all, the importer will be specifically responsible for ensuring that storage and shipping conditions do not adversely affect device properties.
2) New Classification Rules and Related Conformity Assessment Procedures.
As expected, the new text adopts a risk-based classification drawn from GHTF guidelines. Somewhat expected but still, a novelty is the inclusion of point-of-care tests, named in the text as “near-patient tests,” in a category of their own with essentially the same requirements as self-test products: the involvement of Notified Bodies (NB) in judging the user-friendliness of assays and a requirement of in-the-box paper IFUs in the national language.
Although classes A, B, C, and D are risk-based, we aren’t totally escaping “lists,” which are typical of the current IVD directive. In fact, one classification in rule 2 reminds me of parts of the current IVD-D, Annex II, List A and B.
3) More Control Over—and More Power Given to—Notified Bodies.
Faithful to the concept that Notified Bodies act on behalf of the national competent health authorities, the proposed EU IVD regulation provides clear and stricter obligations for member states to continuously monitor the competence and overall performance of NBs.
It also clearly empowers and mandates NBs to strengthen their overview of all economic operators with unannounced audits and physical device or laboratory tests.
Storage and distribution partners and processes won’t be excluded from these assessments, which are dictated by the overall goal of ensuring that devices are safe and effective not only when manufactured but also when they are delivered to end users.
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