The correct classification of in vitro diagnostic medical devices is of high importance for every company. In addition to regulatory intervention by the competent authorities, misclassification may also result in an avoidable delay in the introduction of products onto the market.
In vitro diagnostic medical devices are tests that use biological samples to determine a person's health status. Such tests include pregnancy self-tests, blood glucose tests for diabetics, SARS-CoV-2 tests and even sophisticated diagnoses in clinical laboratories.
Since 26 May 2022, the Regulation (EU) 2017/746 (“Regulation”) on in vitro diagnostic medical devices applies with far-reaching changes compared to the repealed Directive 98/79/EC (“Directive”).
Due to the different risk classes and a large number of transitional provisions, the legal situation is not transparent. For many companies, this raises questions, because in particular approximately 70 % of clinical investigations are based on in vitro diagnostic medical devices.
According to the Regulation, the necessary conformity assessment procedure is now determined on the basis of the four risk classes (A to D) into which each in vitro diagnostic medical device is classified. Depending on the risk class, the involvement of so-called notified bodies is required. In this case, only after the participation of a notified body placing on the market is permitted. The notified bodies according to the Regulation are not identical with those of the repealed Directive.
Compared to the Directive, many more products now require the involvement of a notified body. In practice, this will lead to a delay in making products available on the market. Moreover, the delay is further aggravated by the fact that in the scope of the Regulation there are just seven so-called notified bodies (status July 2022) that perform such a conformity assessment.
As a consequence, early contact with the notified bodies alone can prevent extensive delays; at best, a transitional provision applies that gives the companies more time to carry out a conformity process with the involvement of a notified body.
I. Risk classes
The classification into the various risk classes according to the Regulation is made on the basis of the intended purpose using classification rules.
Only certain products of the risk class A may now be placed on the market by means of a self-declared declaration of conformity. For all other risk classes, the conformity process is carried out with the involvement of notified bodies.
II. Transitional provisions
Starting point: The transitional provisions are only relevant for placing on the market and provision or commissioning of existing products, i.e. products for which a conformity assessment was declared before 26 May 2022 in accordance with the Directive and which do not belong to the new risk class A of the Regulation without sterile labelling.
For products for which a conformity process by notified bodies was already required under the Directive and for which the certificate of conformity was issued before 25 May 2017, the certificate in accordance with the Directive shall remain valid until the date specified in the certificate, latest until 27 May 2025. Certificates issued after 25 May 2017 shall cease to be valid on 27 May 2025 at the latest concerning both the placing on the market and provision or commissioning.
For products for which conformity could be self-declared by the manufacturer according to the Directive and for which a declaration of conformity by a notified body is now required under the Regulation, the following transitional periods apply for the placing on the market, depending on the current classification in the respective risk class: risk class A (sterile) and B until the 26 May 2027, risk class C until 26 May 2026, risk class D until 26 May 2025.
These products may be made available and put into service for one year after the end of the period for placing on the market according to the respective risk class.
It should not be forgotten that the provisions of the Regulation on post-market surveillance, market surveillance, vigilance and registration of economic operators also apply during the period of application of the transitional provisions.
The companies concerned should always carry out the complex classification of their in vitro diagnostic medical devices with the involvement of legal advice. Only then there is a guarantee that no adverse effects will occur after the market launch of the products. At best, this can even accelerate the market launch.
This applies all the more to products to which the transitional provisions do not apply. In these cases, it is crucial that the products are classified as low as possible so that the self-declared conformity can be sufficient.
In many cases, however, transitional provisions make the classification into risk classes temporarily superfluous until a certain deadline, so that in these cases market introduction and further distribution is initially possible without prior conformity assessment according to the regulation.
Dealing with these regulations by exhausting all legal options is only ensured through legal advice.