In-vitro diagnostic medical devices (IVDs) are medical products and function as tests that can, for example, determine a person's infection parameters for certain viruses or make a diagnosis on the basis of the analysis of biological samples. IVDs are assigned to one of four risk classes (A to D) based on their potential risk to individuals and public health.

Class A includes products that pose a low risk to both the public and individuals. These include products such as general laboratory equipment or buffer solutions.

Class D (high-risk group), on the other hand, includes products that test parameters whose detection poses both a high individual and public health risk. Some examples of products in this group are tests for HIV, hepatitis B, or hepatitis C.

Updated: 03.11.2025

The Paul-Ehrlich-Institut monitors the safety of in-vitro diagnostics (IVDs) in group D and some products in group C after their market launch.

The Paul-Ehrlich-Institut is responsible for all products in the highest risk class (D) and some of the products in risk class C, namely tests that are important for infectious diseases, blood group determinations, or tissue compatibility (Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG) section 85 subsection 3). The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for all other IVDs.

One of the main tasks of the Paul-Ehrlich-Institut in the context of IVD vigilance is the centralised recording, evaluation, and assessment of incident reports related to the application of IVDs.

Another task in the field of IVD vigilance is the approval of performance studies. Similar to how other medicines are studied in clinical trials prior to their authorisation, certain IVDs also need to prove their performance capabilities prior to market introduction (see In vitro Diagnostic Medical Device Regulation IVDR, Article 2, number 42). Some performance studies must be approved by the competent higher federal authority before they begin, others only require the submission of a notification.

Updated: 03.11.2025

The Paul-Ehrlich-Institut has been designated by the European Commission as one of the EU reference laboratories (EURLs) for in-vitro diagnostic medical devices since the end of 2023 covering the following two areas:

• tests for the detection of hepatitis or retrovirus infections
• tests for the detection of infections with highly pathogenic respiratory viruses.

The aim of the EURLs is to independently test the quality and performance of high-risk tests (i.e. risk class D tests) prior to market launch to ensure that only reliable diagnostics for dangerous infectious diseases and blood group characteristics are placed on the market in the EU.

An EURL handles a diverse range of tasks. Firstly, the product quality of new IVDs must be examined and the manufacturer's performance specifications must be independently confirmed in the laboratory (performance evaluations). Only after the EURL issues a positive recommendation can the notified body then complete the certification process (CE marking) for an IVD. An EURL also conducts batch testing to ensure consistent quality for product batches on the European market.

The EURL network is also obliged to advise various stakeholders (European Commission, notified bodies, competent authorities) using their expertise and coordinates the development of Europe-wide uniform test procedures, standards, and reference materials.

The EURL at the Paul-Ehrlich-Institut carries out its tasks as an EURL for high-risk infection tests using the more than 25 years of experience and competence of the Testing Laboratory for In-Vitro Diagnostic Medical Devices at the Paul-Ehrlich-Institut (PEI IVD). Since some already certified IVDs are still being tested by PEI IVD due to transitional provisions, the PEI IVD and the EURL at the Paul-Ehrlich-Institut will work in parallel until the end of 2027, after which the PEI IVD will merge into the EURL.

Updated: 03.11.2025

The European Regulation for In Vitro Diagnostic Medical Devices (IVD) EU 2017/746 (IVDR) regulates the conditions under which an in vitro diagnostic medical device receives a CE marking and may therefore be placed on the European market. CE stands for Conformité Européenne – European Conformity – and indicates that a product generally meets the applicable requirements of a European directive. Manufacturers must also take national law into account (in Germany, for example, the Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG) applies).

• The prerequisites for an IVD to receive a CE marking and thus be placed on the market include the following points:
• The manufacturer defines the intended purpose of the product.
• The manufacturer classifies the IVD into one of the four risk classes (A to D) according to the IVDR classification rules (Annex VIII).

• The manufacturer carries out a conformity assessment procedure, which must demonstrate, among other things, that the product meets the general safety and performance requirements (Annex I) in the regulation.

  • The safety, performance, and clinical benefit of the IVD will be reviewed in a performance study.
• The manufacturer prepares the technical documentation (pursuant to Annex II & III IVDR).
• The manufacturer declares that the IVD conforms with the applicable requirements by means of a declaration of conformity.
• A notified body must be involved in the conformity assessment procedure in most cases. Only in the case of risk class A IVDs (non-sterile products) can the manufacturer's conformity assessment be carried out without the involvement of a notified body.

The notified body examines the technical documentation, each individual product, a prototype and/or the quality management system, depending on the conformity assessment procedure. If all requirements are met, the notified body issues the certificate of conformity. Only then may the CE marking be affixed to the product, confirming compliance with the legal requirements. The four-digit number next to the CE marking on the product is the identification number of the notified body that was involved in the conformity assessment procedure. A CE marking must be affixed to the outer packaging of the IVD.

The performance assessment, i.e. the fulfilment of the general safety and performance requirements, is mandatory and is carried out on the basis of data on the scientific validity and on the analytical and clinical performance of a product. Performance studies are carried out to collect this data. Some performance studies require approval from the competent higher federal authority, some only require the submission of a notification. The competent authority in Germany, depending on the IVD, is either the Paul-Ehrlich-Institut or the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).

The Paul-Ehrlich-Institut is responsible for class D IVDs and certain class C IVDs, i.e. all IVDs covered by Rules 1, 2 and 3 (a) to (e) and (g) of Annex VIII to the IVDR. The BfArM is responsible for all other IVDs.

The Paul-Ehrlich-Institut is responsible for the recording, evaluation, and assessment of IVD risks. Tasks in these areas include the assessment of incident reports in the application of IVDs in class D and parts of class C, as well as the review and any necessary approvals of applications for the authorisation of performance studies for these IVDs. However, the Paul-Ehrlich-Institut does not carry out any performance evaluations itself and does not award CE markings. Independent examinations by the Paul-Ehrlich-Institut, such as examinations of IVDs newly placed on the market, are not necessary due to the conformity assessments carried out by the notified bodies.

Updated: 03.11.2025

The European In Vitro Diagnostic Medical Device Regulation (Regulation EU IVDR 2017/746) classifies in vitro diagnostic medical devices (IVD) according to the medical purpose for which a product is to be used. The intended purpose determines – depending on the risk to individuals and public health – the product's classification into one of the four risk classes (A to D):

• Risk class A: This class includes products that pose a low risk to both public health and individuals, such as products for general laboratory use or buffer solutions.
• Risk class B: All IVD products that do not specifically fall under one of the seven classification rules of the IVDR (Annex VIII) are assigned here, as well as certain self-testing devices (e.g. pregnancy tests). An incorrect result from one of these products poses a moderate risk to individuals and a low risk to public health.
• Risk class C products pose a high risk to individuals and a moderate risk to public health if they produce an incorrect result. This class includes cancer screening tests, companion diagnostics, and self-testing devices that are not explicitly assigned to class B.
• Risk class D: This class includes products that pose both a high individual and public health risk. Some examples of products in this group are tests for HIV, hepatitis B, or hepatitis C.

The classification of an IVD is carried out by the manufacturer, who is guided by the implementing regulations and classification rules in Annex VIII of the IVDR. The "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746" by the European Medical Device Coordination Group (MDCG) provides IVD manufacturers with correct classification information and examples.

A notified body must be involved in the conformity assessment procedure for class A IVD devices placed on the market in a sterile state, as well as for class B, C and D devices. The certificate of conformity issued by the notified body is a prerequisite for affixing a CE marking and thus being placed on the market in the EU. If there are differences of opinion between the manufacturer and the notified body about the risk class, the competent national authority shall be consulted for the classification. The competent national authority in Germany is the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in accordance with section 85 subsection 2 sentence 1 number 1 of the Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG).

Updated: 03.11.2025