IVDR – In Vitro Diagnostic Regulation – is the new 2017/746 European regulation on in vitro diagnostic (IVD) medical devices, which came into force in May 2022. It is designed to ensure greater efficiency and harmonize rules across the EU. At the same time, it reinforces safety levels for patients. The transition to IVDR is therefore essential for in vitro diagnostics manufacturers and operators on the European market. Let’s take a look at the new regulations. What type of equipment is affected? What changes are involved? And how can we ensure regulatory compliance?
What is an IVD MD?
Let’s start by clarifying what an IVD MD or “In Vitro Diagnostic Medical Device” is. The definition is broad, it corresponds to any element designed by the manufacturer for the in vitro analysis of human biological matrices (urine, blood, tissue, etc.):
- reagent;
- sample container;
- instrument, apparatus, equipment;
- calibration device;
- software or any system.
The analysis is carried out with the aim of providing different types of information:
- on a physiological or pathological process or state;
- on physical or mental birth defects;
- on predisposition to pathology or disease.
It may also concern other applications, such as:
- determining safety and compatibility with potential recipients;
- predicting a response or reaction to treatment;
- the definition or control of therapeutic measures.
IVDR: what is the purpose of the new EU 2017/746 IVD regulation?
IVDR repeals the In Vitro Diagnostic Devices Directive (IVDD) 98/97/EC. After a 5-year transition period, the new regulation came into force on May 26, 2022. Since this date, all in vitro diagnostic devices placed on the European market must comply with this regulation.
The new regulation meets the increased safety requirements in the field of medical diagnostics. What’s more, the regulation does not need to be transposed into the national legislation of EU member states, limiting the risk of differing interpretations in different countries. In this way, the IVDR also facilitates European harmonization, with optimal governance of the medical device sector within the EU. In addition, by better aligning with technological developments, it will enable us to better adapt to innovation and enhance the image of medical device brands.
New European regulation on in vitro diagnostic devices: what’s changing?
Overall, the new European regulation EU 2017/746 (IVDR) has redefined the classes of In Vitro Diagnostic Devices (IVDs), as well as the evidence of their analytical performance. Analyses are more exhaustive and more demanding. Using a laboratory accredited to EN ISO/IEC17025:2017 can enhance data reliability and accuracy. It will therefore facilitate the transition to IVDR, with better guarantees of compliance and appropriate support.
Here are the main areas of change introduced by IVDR.
Classification of diagnostic devices according to risk level
The IVDR has defined 4 classes (A to D), from the lowest level of risk to the highest.
| Device category | Risk description | Examples of equipment/tests |
| A class | Low risk to patients and public health | Instruments, containers, prepared selective culture media |
| B class | Moderate risk for patients and/or low risk for public health | Self-tests (pregnancy, urine, cholesterol, etc.) |
| C class | High risk for patients and/or moderate risk for public health | Blood glucose self-tests, infectious disease tests, cancer markers |
| D class | High risk for patients and public health | Blood compatibility tests, hepatitis testing of blood donors, tests for fatal diseases |
More rigorous clinical evidence of device performance and safety
Based on the performance evaluation report, diagnostic tests must be supported by clinical demonstrations and demanding technical information.
Conformity assessment of high-risk devices by notified bodies
The evaluation of class B, C, and D devices must be entrusted to a notified body. It is more rigorous than before, and varies depending on the material. For class D devices, additional assessment by a European Union reference laboratory is also required.
Reinforced surveillance
Manufacturers are subject to monitoring by Notified Bodies (NBs), which themselves are controlled by EU member states. Pharmacovigilance requirements are also more stringent. The evaluation of device performance must, moreover, be carried out post-marketing and throughout the life of the product.
Increased transparency and traceability
Information about the devices and their performance is public. They are available in a new European database on medical devices (EUDAMED). Incident notification times have been extended, and incident reports are integrated into the database.
Responsibility extended to all operators
Responsibility for the conformity of medical devices is explicitly assigned to all economic players in in vitro diagnostics:
- manufacturers;
- authorized representatives;
- importers and distributors of in vitro diagnostic devices in the European Union;
- regulatory affairs or quality management professional involved in IVD.
How to be well supported towards IVDR transition?
The changes induced by the IVDR not only involve specialized and additional expertise, but also a significant workload and costs. According to Euractiv, in December 2023, 80% of in vitro diagnostic devices were subject to control by a notified body. This corresponds to approximately 24,000 devices!
Good support in monitoring the performance and safety of IVDs is therefore crucial for companies in the medical device sector. Compliance with EU regulation 2017/746 is essential. And faced with the shortage of notified bodies, highlighted by the In Vitro Diagnostic Industry Union (SIDIV), the risks of delay in marketing are significant for those who have not found a reliable and compliant partner.
The keys to a successful transition to IVDR are:
- Hire a laboratory specializing in the analytical performance of in vitro diagnostic devices. ISO/IEC17025 accredited for this activity, it will allow you to better guarantee regulatory compliance.
- Get help managing quality management system plans and reports.
- Carry out a gap analysis: this process consists of comparing the current situation with the projected situation, with the aim of identifying the strategies necessary to close the identified gaps.
- Register on the European EUDAMED database.
- Get support for post-marketing surveillance and material vigilance.
Amarok Biotechnologies, a trusted ISO/IEC 17025 accredited partner for IVD performance evaluation
In France, Amarok Biotechnologies is the first laboratory to be accredited to EN ISO/IEC17025:2017 for the evaluation of the analytical performance of in vitro diagnostic medical devices. This recognition by COFRAC’s Human Health division enables us to offer our customers the best guarantees of regulatory compliance and a successful transition to IVDR. Added to our expertise in IVD-MD data generation and performance testing, since 2011, this recognition by COFRAC’s Human Health division enables us to offer our customers the best guarantees of regulatory compliance and a successful transition to IVDR.
The implementation of a rigorous quality policy has also been at the heart of the company since its creation. Its analytical performance evaluation laboratory, as well as all its activities, are ISO 9001:2015 certified.
The laboratory is also involved in consultancy, expertise and training missions for its various branches, including R&D. This makes the company a partner of choice when it comes to supporting and compiling regulatory dossiers.
Do you need a partner or information to guide you towards IVDR? Please contact us.