IVD Consulting and Registration - In-Vitro Diagnostic

Unlike in the USA, IVDs are categorized into 4 risk classes. However, many of the requirements are the same. Only the structure of the Technical Documentation (Technical File) and some specific requirements differ.

In addition, there are requirements for labelling, registration with the UDI or the European representative that differ fundamentally from the US requirements. The distribution to dealers or the requirements for importers must also be taken into account. In any case, the performance data of the respective test must be verified. It is therefore helpful if the IVD has already been sold on the US market and its performance (specificity, sensitivity) has been proven. As a rule, there are no special limit values or acceptance criteria. The system follows a risk-based approach.

IVD Consulting and Registration are essential for ensuring compliance with EU regulations for In-Vitro Diagnostics. Like other Medical Devices, they are categorized into different groups for the purpose of assigning the applicable conformity assessment procedures and risks for the user. To do this, the respective tests or procedures must first be classified in accordance with Chapter V of the Regulation on In Vitro Diagnostics. There are 4 Risk Classes (A, B, C and D). The requirements for the products of the respective groups are basically the same, but class A products can be brought to market relatively easily, since the involvement of a Notified Body is not required (except for sterile products).

The evaluation of Class B, C and D products always takes place in collaboration with Notified Bodies. Unfortunately, there are only a limited number of these bodies, which often makes the implementation of certain projects very difficult. Possible bodies can be researched under the keyword “Nando” on the EU server (search “Legislations”, select Regulation 2017/746, now you can see all the notified bodies for IVDs; as of June 2023, there are 10 of them for all IVDs WORLDWIDE that are placed on the market in the EU). Despite extended transition periods, this bottleneck will become an economic problem for the Medical Device industry.

In vitro diagnostics must also be accompanied by Technical Documentation in accordance with Annex II of the Regulation. In addition, manufacturers have further obligations (the manufacturer does not necessarily have to “manufacture”; producers can do this) through the implementation of a Quality Management System (QM system), the implementation of the Risk Management System, Post-Market Surveillance, registration with Eudamed, the appointment of a Responsible Person and many other points. Proof of the “functioning” of the IVD is provided by the performance evaluation. Here, too, there are several possibilities.

When placing the device on the market, sensitivity and specificity are essential factors. The acceptance of these values can be the result of Risk Management and must be included in the instructions for use.

According to the “German Network for Evidence-Based Medicine”, the term sensitivity means: the proportion of test-positive persons among all persons with a disease in a sample. Ultimately, it is the probability of identifying those who are actually sick with a test. A high level of sensitivity is sought when a disease is to be ruled out with a high degree of certainty.

Specificity, on the other hand, describes the proportion of test-negative individuals among all non-diseased individuals in a sample. The statement behind the value is intended to represent the probability of correctly identifying healthy subjects with a test.

The “quality” of a test is then determined by the product of specificity and sensitivity. This can very quickly lead to a test not being “meaningful” because the accuracy of detection is only 50-70%. In these cases, the patient is made to feel too insecure and further measures to detect diseases are indicated (e.g. biopsy).

CE Mark certification for IVD (In Vitro Diagnostics) is one of our core competencies. We invite you to contact us for a non-binding consultation.