IVDR Classification for In Vitro Medical Devices Explained

The EU 2017/746 In Vitro Diagnostic Regulation (IVDR) is a pivotal piece of legislation enacted by the European Union, specifically designed to govern in vitro diagnostic medical devices. It replaces the older In Vitro Diagnostic Directive (IVDD), ushering in a new era of regulation that significantly enhances safety and oversight.

Effective from May 26, 2022, IVDR introduces a comprehensive risk-based classification system that requires most in vitro diagnostic devices to undergo rigorous conformity assessments by a Notified Body (NB). This new framework underscores the EU’s commitment to improving patient safety and device reliability, setting it apart markedly from the regulations under IVDD. The updated version of the extended deadlines and further information can be found here.

IVDD vs. IVDR: Key Differences

The transition from IVDD to IVDR marks a substantial shift in regulatory requirements. Under IVDR, up to 90% of in vitro diagnostic devices on the EU market are now subject to a conformity assessment by a Notified Body. 

This is a stark contrast to the previous directive, where many IVDs could be self-certified. The new regulation’s complexity and stringent criteria reflect advancements in technology and an increased understanding of risks associated with diagnostic devices.

The IVDR’s classification system, unlike the IVDD’s approach, is governed by a detailed set of rules that all IVD manufacturers must follow to categorize their devices accurately.

Understanding the IVDR Classification System

The IVDR classification system is designed to group IVD devices based on their risk level, taking into account both patient safety and public health. This system is modeled similarly to the EU Medical Device Regulation (EU MDR), but with specific considerations for the unique nature of in vitro diagnostics. Here’s a breakdown of the four risk classes established by IVDR:

• Class A: Devices with low patient and public health risk. Examples include specimen receptacles, laboratory instruments, and buffer solutions.

• Class B: Devices with moderate patient risk or low public health risk. This category includes self-testing devices such as pregnancy tests, fertility tests, and cholesterol tests. Class B is also the default classification for IVDs not covered by other rules.

• Class C: Devices with high patient risk or moderate public health risk. This includes tests for detecting infectious agents without a high risk of spread or agents that could cause severe illness or death if erroneous results occur.

• Class D: Devices with high patient risk and significant public health risk, such as those detecting life-threatening transmissible agents or infectious diseases with high propagation potential.

The Seven Classification Rules Under IVDR

To help manufacturers navigate the new regulatory landscape, IVDR outlines seven specific rules for device classification. These rules are based on the intended purpose of the device and the risks associated with its use. Here's a concise overview of the seven classification rules:

Rule 1: Devices intended for performance of a task without direct contact with the patient's body are classified in Class A.

Rule 2: Devices intended for near-patient testing are classified in Class A or Class B, depending on the impact of erroneous results on the patient.

Rule 3: Devices intended for self-testing are classified in Class A or Class B, depending on the impact of erroneous results on the patient.

Rule 4: Devices intended for professional use and for which the test results are not used directly to make decisions concerning medical treatment are classified in Class B or Class C, depending on the impact of erroneous results on the patient.

Rule 5: Devices intended for use in laboratory medicine are classified in Class B, Class C, or Class D, depending on the intended purpose and the impact of erroneous results on the patient.

Rule 6: Devices intended for near-patient testing and providing information directly used to make decisions concerning medical treatment are classified in Class C or Class D, depending on the impact of erroneous results on the patient.

Rule 7: Devices intended for self-testing and providing information directly used to make decisions concerning medical treatment are classified in Class C or Class D, depending on the impact of erroneous results on the patient.

Impact of IVDR Classification on CE Marking

Under IVDD, many IVDs could obtain CE Marking through self-certification. In stark contrast, IVDR mandates that nearly all IVDs, except Class A, non-sterile devices, require assessment by a Notified Body.

This shift significantly increases the workload for Notified Bodies, prompting the European Commission to delay IVDR’s full implementation. Despite the delay, manufacturers must proactively engage with Notified Bodies to avoid potential bottlenecks.

Notified Bodies need to be accredited to be able to issue certificates under the IVDR. Currently, there are only 12 NBs accredited to do so. It's important that manufacturers check whether their Notified Bodies of choice is actually accredited to issue certificates under the IVDR and if not, where they are in the process.

Mandatory Quality Management Systems (QMS) and Documentation

IVDR stipulates that all IVD manufacturers, excluding Class A, non-sterile devices, must implement a robust Quality Management System (QMS). Compliance with ISO 13485 is mandatory, and manufacturers must have their QMS, Technical File, or Design Dossier audited by a Notified Body (Except for class A, they can still do self certification).

Successful audits could result in CE Certification and an ISO 13485 Certificate. Following certification, manufacturers must submit a Declaration of Conformity as per Annex IV of IVDR, affirming compliance with EU regulations. This Declaration is essential for affixing the CE Marking to the product.

Note: All IVDs, except Class A, non-sterile devices, will undergo audits by a Notified Body to ensure ongoing compliance with IVDR.

Streamlining IVDR Compliance with Matrix Requirements

Transitioning to a risk-based classification system under IVDR underscores the critical importance of thorough risk analysis.

At Matrix Requirements, we recognize the vital role of risk management in ensuring the safety and efficacy of IVD products. Our QMS software provides your design control needs as you develop your Medical Device. Reach out to the team at Matrix Requirements to learn more!