What is IVDR Certification and Why is it Important for IVD Manufacturers

 It's striking, yet true, that the global market size for in vitro diagnostics is projected to show a compound annual growth rate of 5.34% until 2030. Now, this massive growth comes with new rules. Medical device companies in Europe are now required to adhere to more stringent regulations. Among those changes is obtaining IVDR certification for their products.

IVD remains the largest market in the global medical devices market, representing 13% of the total devices market as of 2024. But with growth comes responsibility. Companies must demonstrate that their products are safe and effective. This is where IVDR certification is critical.

What Is IVDR Certification?

IVDR is the short form of In Vitro Diagnostic Regulation. This rulebook from the European Union comprises rules for medical tests that doctors administer to determine if you have any illnesses. Consider blood tests, pregnancy tests, COVID-19 tests, or those genetic-testing kits. All of these require IVDR certification to sell in Europe.

The new In Vitro Diagnostic Medical Devices Regulation (IVDR) replaced the old IVDD rules, officially applying on 26 May 2022. This shift represented one of the most critical regulatory shifts in the medical device industry for decades. Instead of the old IVDD standards, companies can now be held to the new IVDR provisions.

IVDR certification is the equivalent of a safety stamp. This proves that a medical test device meets all European safety and quality requirements.  The certification covers basic home pregnancy tests as well as sophisticated lab-based hospital tests. The certification is essential for market access because products cannot be sold in Europe without it.

Why Did Europe Invent These New Rules?

The former IVDD system was lax. And some medical tests made it to market without being checked well enough. Concerns about incidents in patient safety and quality had underlined the call for greater scrutiny. The new rules under the IVDR are far more stringent. They ensure that all medical tests are thoroughly vetted before people can use them.

Under IVDD, a lot of tests had very little oversight. Approximately 80% of IVDs would be eligible for self-registration to the market. Nearly every medical test now requires independent board approval. That serves to protect patients and to give doctors confidence in the results of the test.

And the COVID-19 pandemic made apparent deficiencies in the old system, too. Many rapid tests came onto the market, but at differing quality levels. IVDR seeks to avoid these issues by ensuring strong clinical evidence and post-market surveillance are present.

Key Changes Under IVDR

The contrasts between the old and new systems are substantial. Under IVDD, a lot of tests could self-certify. IVDR changes this completely. These days, the vast majority of medical tests require approval from independent organizations known as notified bodies.

The IVDR establishes a risk-based classification system consisting of four classes (i.e., A, B, C, and D), where class A corresponds to the lowest risk and class D represents the highest risk. More hazardous devices need a more rigorous scrutiny process. This classification dictates how much control is required.

The rule also mandates heavier reliance on clinical evidence. Companies have to demonstrate that their tests work in real-world settings. They require clinical performance studies evidencing that their devices work as they should. The new rules also highlight software- and AI-based tests, which were not as extensively addressed under IVDD.

Another significant change is the implementation of Unique Device Identification (UDI) systems. Every building block must be identifiable in a unique way and traceable during its lifetime. This enhances the traceability and provides in case of security problems or recalls.

The Certification Process

IVDR certification is a long process and is quite complex. The companies would need to classify the products themselves in line with the new risk categories first. This, in turn, leads to a requirement for complete technical documentation proving safety and performance. Such documentation may comprise, but is not limited to, clinical data, risk assessment, QMS, and PMS.

20,424 applications have been filed, and 6,978 certificates have been granted as of May 2024. It suggests the high need, but also the fact that this would all take time. Acceptance rates differ according to product type and complexity.

Most products require certification by notified bodies. These are independent bodies nominated by EU member states to verify compliance. Currently, there are only a handful of notified bodies designated for IVDR, and this is causing a bottleneck in the system. These companies will scrutinize your paperwork and may even visit your facilities. It could take between 6 and 18 months to get the job done, depending on the class of product and its complexity.

For Class D product panels, there may be other expert committees involved. Such panels consist of clinicians who review the most significant diagnostic tests. This is an additional level of review for high-risk devices.

Timeline and Transition

Clear compliance benchmarks are established for different device classes by the European Union's adoption of the In Vitro Diagnostic Regulation (IVDR). Manufacturers must apply to a Notified Body (NB) by May 26, 2025, and develop an IVDR-compliant Quality Management System (QMS) for IVDD-certified products. A formal agreement must be completed by September 26, 2025. As long as certificates are still valid under Article 110(2), this guarantees a transition deadline of December 31, 2027, giving enough time for regulatory adaption.

The timeline for self-declared Class D and Class C devices is comparable, if a little different. Class D and IVDD-certified devices have the same timeframe, with all actions due in 2025 and a transition deadline of December 31, 2027; however, Class C devices are granted an extension of one year. The agreement must be finalized by September 26, 2026, with the QMS implementation and NB application due by May 26, 2026, and the ultimate transition date set for December 31, 2028.

The devices with the longest timeline are self-declared Class B and sterile Class A devices. The NB application and the necessary QMS must be completed by May 26, 2027, and the agreement must be signed by September 26, 2027. The final compliance deadline for these devices is December 31, 2029, which provides an extended transition period. In addition to facilitating a more seamless regulatory transition across device categories, this phased approach aids manufacturers in planning and resource alignment.