Regulation (EU) 2017/746: In vitro Diagnostic Medical Device Regulation (IVDR)  
February 2024 

The European In Vitro Diagnostic Medical Device Regulation (IVDR) must be followed by manufacturers who wish to place in vitro diagnostic medical devices on the market in the EU.

The Regulation (EU) 2017/746 In vitro Diagnostic Medical Device Regulation (IVDR) regulates the entire life cycle of in vitro diagnostic medical devices (IVDs) in the European market. The IVDR came into force on May 25, 2017 at the same time as Regulation (EU) 2017/745: Medical Device Regulation (MDR), which regulates all other medical devices and their accessories. The IVDR has been valid since May 26, 2022. A timeline and explanations of the transitional provisions can be found in this article. 

In this article, we would like to give you an overview of the IVDR, the relevant stakeholders, its structure, the requirements, as well as background information on the legal act. We have provided links to other articles from the Johner Institute on the respective topics to help you familiarize yourself with this sometimes difficult topic.

1. Who does IVDR concern? 

1.1 Scope

The IVDR is responsible for the entire market for IVDs in the EU, from development and market surveillance through to use. In particular, the IVDR regulates the requirements that IVDs must fulfill to be placed and operated on the European market.
 

Other products such as reagents, calibrators, control materials, instruments, and specimen receptables are also considered in vitro diagnostics under the IVDR. 

1.2 Affected organizations
 

• Thus, the main addressee of this Regulation are the manufacturers of IVDs.
• Other economic operators who must comply with the requirements of the IVDR are distributors, importers, manufacturers from third countries, and their authorized representatives. 
• In addition to the economic operators, the IVDR also imposes requirements on the competent national authorities and the notified bodies, which are included in the conformity assessment of a significantly wider range of IVD products in comparison to the old IVDD. 
• The third sub-group, which is held responsible by the IVDR, are health institutions such as hospitals and clinics that operate IVDs or laboratories that act as manufacturers of self-developed in-house IVDs. 

1.3 Further tips
 

3. Overview of the requirements of the IVDR 

Now that the design and structure of the IVDR are known, we will look at the requirements for manufacturers (3.1) and the requirements for other economic actors such as distributors, importers, and laboratories (3.2). 

3.1 Requirements for the manufacturers themselves and their IVDs 

Table 3 shows the requirements for IVD manufacturers. If the manufacturer seeks IVDR compliance for one of its IVDs, he must establish a quality management system and maintain it throughout the entire life cycle of the products. ISO 13485 is the harmonized standard to be regarded here. 

3.1.1 Requirements for the manufacturers 
 

Table 3: Requirements for manufacturers, their systems, and roles

3.1.2 Product-specific requirements

In addition to the cross-product requirements, there are also requirements for each individual product. These product-specific requirements result from the intended purpose of the respective IVD. This, in turn, results in the qualification as an IVD, the classification into one of the four risk classes, the requirements for performance evaluation, product-specific risk management, and labeling. Further verification and validation activities, such as usability or stability verifications, as well as the development file, are also part of technical documentation. Post-market surveillance and vigilance are also product-specific tasks that manufacturers must fulfill according to the IVDR.   

Another new obligation for manufacturers is the assigning of a UDI for each IVD and its registration in EUDAMED. This is intended to facilitate traceability and post-market monitoring for all stakeholders. In summary, the technical documentation of an IVD according to Annexes II and III serves to prove that all valid general safety and performance requirements (Annex I) are met. Table 4 provides an overview of these product-specific requirements.

Table 4: Requirements of the IVDR for the devices

3.1.3 Note on fulfilling the requirements
 

3.2 Requirements for other (economic) actors 

In addition to IVD manufacturers as addressees of the IVDR, other stakeholders are affected. Table 5 shows a list of other (economic) actors within the scope of the IVDR. 
 

Table 5: Requirements of the IVDR for other economic actors

4. Background information on the act 

4.1 How EU Regulations 2017/175 MDR and 2017/176 IVDR came about 

It is still unclear why the EU tackled the new regulation of the medical device and IVD market in 2017. The breast implant scandal is discussed as a trigger event, but this is denied by the actors involved. However, the aim of the regulations is to ensure the safety and health of patients, as well as a barrier-free EU market for medical devices. 

4.2 Difference between EU regulations and EU directives 

The "old" EU Medical Device Directive, like all EU directives, had to be transposed into national laws and national regulations to become applicable as national law. In Germany, this was realized by the Medizinproduktegesetz (MPG). 

The EU regulations (here: MDR, IVDR) have a direct legal character. National laws only supplement these regulations with penal provisions and the determination of the competent authorities. 

4.3 Changes to the IVDR compared to the IVDD

This article highlights the changes introduced by the IVDR compared to the old IVDD, the In vitro Diagnostic Device Directive.

5. Conclusion and Summary 

The In Vitro Diagnostic Device Regulation (IVDR) is a very comprehensive body of legislation that poses major challenges for all stakeholders (manufacturers, notified bodies, importers, distributors, laboratories). 

In contrast to the IVDD, the IVDR has not only significantly increased the regulatory requirements but also expanded the scope of validity. Products such as in-house IVDs (labdeveloped tests, LDT) are now subject to IVDR. 

The actors have no choice but to deal intensively with this body of legislation and to meet its requirements. These increased requirements apply to both the "authorization" (pre-market phase) and, explicitly, the post-market phase (post-market surveillance, vigilance). 

6. Further articles and links 

6.1 Classification

The risk class of an IVD is decisive for the regulatory effort that manufacturers must pay to prove compliance. In this article, you can get an overview of the classification of IVDs according to EU Regulation 2017/746 and you will be instructed on how to classify products in a clever and legally compliant manner. 

6.2 Transitional provisions

The EU has postponed the transition periods for the IVDR several times. The rules are so complex that an article on the transitional provisions will help you. 

6.3 Special IVDs

In another article by the Johner Institute, so-called sampling kits are discussed in detail. From a regulatory point of view, these sets are close to the MDR's treatment units. In short, several products can be combined into a sampling set if their intended purpose is not changed. 

IVDs for self-administration (self-testing) and patient-related tests have been an important part of the healthcare system in Europe, not only since Corona. In this article, we have summarized the regulatory specifics for these IVD products. 

6.4 Further regulatory requirements

There are many other laws and standards to be observed, which are presented in the article on the approval of IVDs. 

Further explanations and requirements have been published by the Medical Device Coordination Group (MDCG). 
 

Assistance with the implementation of the IVDR
 

Change history (as of May 2021; Remainder deleted) 

• 2024-02-25: Chapter numbering revised, subheadings added 
• 2024-01-25: Article revised  
• 2023-05-03: Article completely rewritten