MDR and IVDR: differences and similarities of the regulations

Since the MDR came into force, it has been a daily companion in the medical sector. The MDR has brought with it a number of changes that manufacturers, among others, must take into account. For example, the essential safety and performance requirements (formerly the essential requirements), the clinical evaluation – which places significantly higher demands on the quality of the clinical data – the product identification (UDI), the technical documentation and the classification.

But how do MDR and IVDR differ? And what are the similarities? An overview.

by Bernd Müller

Not all medical devices fall under the MDR. A large number of medical devices and applications are classified as in vitro diagnostic devices (IVD). What falls under the term “in vitro diagnostic device” can be defined with the help of the intended purpose of the product and Article 2 of Regulation (EU) 2017/746 (IVDR).

It becomes obvious that as a software service provider in the medical industry, it is not sufficient to focus on the requirements of the MDR. We have therefore addressed the following problem:

What are the main similarities and differences between the MDR and IVDR?

At first glance, the regulations hardly differ from each other in structure and chapters. With 123 articles, the MDR is somewhat more extensive than the IVDR with 113 articles.

Conformity assessment procedure
Both regulations follow the basic idea that the essential safety and performance requirements must be demonstrably fulfilled within the framework of a conformity assessment procedure. For products of risk class A, the conformity assessment procedure can take place without the involvement of the Notified Body.
Risk-based classification of products
The IVDR also follows the risk-based classification of products. In contrast to the MDR, however, there are product classes A, B, C and D. Identical to the MDR, the classification is based on the intended purpose of the product.
For the classification of the products into the respective product class, the regulation provides seven rules in Annex VIII, with which the classification is made. Products with the lowest risk are assigned to risk class A and with ascending risk to risk classes B, C and D accordingly.
Software
In addition, the IVDR has concretised the requirements for software and thus drawn an equivalence to the MDR. For example, the requirements for interoperability, IT security and documentation must be demonstrated. Furthermore, the software must be developed according to the software life cycle.
Technical documentation
For IVDR products, manufacturers are also obliged to prepare and maintain technical documentation on the product. The requirements for technical documentation are described in Annex II of the Regulation.
The requirements reflect the different scopes of the MDR and IVDR. The IVDR, as expected, focuses on the analytical performance of the product and the associated parameters, such as accuracy, sensitivity, specificity and test limits.
Performance evaluation
Furthermore, the IVDR requires the performance evaluation to be carried out, which is the equivalent of the clinical evaluation under the MDR. The performance evaluation is intended to support the intended purpose of the product and is carried out according to precisely defined and methodical procedures to demonstrate the aspects of scientific validity, analytical performance and clinical performance.
How the performance evaluation is to be planned, conducted and documented is set out in Annex XIII of the IVDR. In addition, the IVDR refers in the preface (66) to ISO 20916, which is a supplement to the specifications, planning and performance of a performance study.
Launching, vigilance and market surveillance
Equally important issues addressed by the IVDR are post-market surveillance, vigilance and market surveillance. The IVDR does not deviate from the approach of the MDR and requires proactive monitoring by manufacturers (post-market surveillance), a reactive procedure by manufacturers (vigilance) and monitoring by the authorities (market surveillance).

In summary, there are many synergies between the MDR and IVDR. Therefore, working under the scope of the IVDR does not mean a complete rethink of the MDR. The substantiation of the essential safety and performance requirements continues to be the principle of the conformity assessment procedure.

As a software service provider in the medical technology sector, we are looking forward to the synergies, especially the concretisation of the requirements for the software.

BAYOOCARE and BAYOOMED work with a wide range of customers in medical technology with the aim of developing compliant solutions for various applications. It is therefore essential that we, as software service providers, know, take into account and live the requirements of the MDR.

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Feel free to contact us. We support you in regulatory issues, quality assurance measures through to post-marketing surveillance.