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The IVDR (Regulation (EU) 2017/746) regulates the entire in-vitro diagnostics (IVD) market in the European Union and is aimed at manufacturers, distributors, importers, laboratories, users, notified bodies and national authorities. In the "General safety and performance requirements", the IVDR precisely defines the requirements that in vitro diagnostic medical devices must fulfill in order to ensure the safety, performance and reliability of the products. These requirements apply to all phases of the life cycle of an IVD, from development and approval through to market surveillance.

Manufacturers of medical devices in particular are confronted by the IVDR with extensive requirements that affect both the manufacturer itself and the IVD product. The central requirements include

Quality management and documentation:

• Implementation of a comprehensive QM system: A robust quality management system (QMS) must be implemented to ensure continuous compliance with IVDR requirements and to guarantee the quality of products throughout their life cycle.

• Detailed technical documentation in accordance with Annex II and III: For each IVD product, detailed technical documentation is required that includes all relevant information to demonstrate the safety and performance of the product. This includes product design, clinical data and risk analysis.

• Appointment of a responsible person for regulatory compliance: A qualified responsible person must be appointed to ensure that all regulatory requirements are met in accordance with the IVDR. This person is responsible for ensuring proper compliance and regularly updating the technical documentation.

Manufacturers of in-vitro diagnostics (IVD) are obliged to introduce a quality management system (QMS) that is effective not only in the development and production, but also in the market surveillance of the products. With the exception of class A products, certification of the QMS is generally required.

In addition to the QMS, the IVDR (In Vitro Diagnostic Medical Devices Regulation) also requires the implementation of a risk management system that ensures that a positive balance is struck between the benefits and risks of the product throughout its entire life cycle.

In order to ensure regulatory compliance in accordance with the IVDR and to ensure that the technical documentation is prepared in accordance with the manufacturer's own quality management system, manufacturers must also appoint a person responsible for regulatory compliance. This person is responsible for ensuring proper compliance with regulatory requirements and the continuous monitoring of compliance.

The In Vitro Diagnostic Medical Devices Regulation (IVDR) sets out product-specific requirements that provide for a risk classification for each IVD product and software IVD. Manufacturers must determine the appropriate risk class for each product in order to meet the requirements of the regulation.

The technical documentation of an IVD must comply with the essential safety and performance requirements set out in Annex I of the IVDR and meet the requirements of Annex II of the IVDR. To demonstrate compliance with these requirements, manufacturers must apply harmonized standards and, where applicable, the Common Specifications.

Continuous performance evaluation is required to ensure the safety, performance and benefit of the IVD. If clinical data are insufficient, an additional performance study must be conducted.

Another important point of the IVDR is the unique identification of the product by means of "Unique Device Identification" (UDI), which results in the registration of the product in the European database for medical devices (EUDAMED). Furthermore, the IVDR places requirements on instructions for use, accompanying materials and labeling (imprints and packaging).

Depending on the risk class of the product, manufacturers undergo a conformity assessment procedure. For products in risk classes B, C and D, the involvement of a notified body is required in order to obtain the CE mark and draw up a declaration of conformity. Products in risk class A are exempt from this.

In addition, the IVDR obliges manufacturers of IVDs to monitor the entire life cycle of their products on the market. This includes the collection of data as part of post-market surveillance and vigilance in order to identify potential risks at an early stage and take the necessary measures. If risks are identified, the authorities must be informed immediately.

As outlined above, the IVDR places extensive requirements not only on manufacturers of IVDs, but also on other players in the market, including importers, distributors, hospitals and operators, laboratories acting as manufacturers of in-house IVD products, as well as suppliers of "For Research Use Only" (RUO) products and pharmaceutical manufacturers. All of these players must ensure that they meet the requirements of the regulation in order to guarantee the safety and performance of IVD products on the market.

The IVDR Regulation introduces significant innovations and differs from the previous IVDD Directive in key respects:

The scope of the IVDR Regulation has been significantly expanded compared to the IVDD. It now also includes high-risk products that are used exclusively in a single healthcare facility, as well as in vitro diagnostic medical devices that provide diagnostic services - including internet-based services, genetic testing and other tests that indicate a patient's predisposition to certain diseases or the effect of treatments.

The IVDR introduces a new classification system based on the risk rules of the Global Harmonization Task Force (GHTF). This system distinguishes between risk classes A to D, with class A representing products with a low risk and class D products with the highest risk. Classification is carried out in accordance with the rules for the correct classification of IVD products.

According to the IVDR, manufacturers of in vitro diagnostic medical devices must designate a qualified person who is demonstrably responsible for compliance with the regulatory requirements within their organization.

The IVDR also extends the role of notified bodies. In many cases, the new risk-based classification system requires the involvement of a notified body in the approval of IVD products, which significantly increases the number of products to be tested (with the exception of class A products). The requirements for the designation and monitoring of notified bodies have also been significantly tightened, as competent authorities and reference laboratories must now be involved in the conformity assessment of high-risk devices. These changes are likely to lead to longer conformity assessment procedures.

The introduction of Unique Device Identification (UDI) facilitates the traceability of products in the event of a safety incident and enables a faster and more efficient recall of IVD products.

In addition, the IVDR Regulation places higher demands on technical documentation and clinical evaluations. These must now be more detailed. The regulation also requires manufacturers to carry out performance studies and demonstrate that their products meet the requirements of the respective risk class in terms of safety and performance. This assessment must also be continued after the product has been placed on the market in order to identify potential safety risks at an early stage and be able to respond to them.