How are devices classified under the IVDR?

Much like the MDR, the IVDR provides guidelines for manufacturers to classify IVDs by intended purpose and risk. Class A presents the lowest risk and Class D the highest risk. This includes risks like incorrect or delayed diagnosis, which could lead to inappropriate treatment, and risks to healthcare workers handling the devices. The regulation ensures that these risks are minimized through careful design, testing, and validation of the devices before they reach the market. Here’s a table summarizing the 4 risk classes:

The full classification rules are outlined in Annex VIII of the IVDR and are based on the Global Harmonization Task Force (GHTF) guidelines.

What are the rules for classifying IVDs?

The classification of an IVD is determined by a set of rules covering the intended purpose, the degree of invasiveness, the level of risk posed to patients and public health, and the impact of the device on clinical outcomes. Here’s a summary of the 7 rules:

Rule 1: Devices intended for detecting or diagnosing conditions or infections that pose a high public health risk, such as communicable diseases, fall into Class D.

Rule 2: Devices intended for detecting or diagnosing conditions that pose a serious risk to patients, like cancer markers, are classified as Class C.

Rule 3: Devices used for therapeutic monitoring or to determine the state of health to inform treatment decisions are generally classified as Class C or D depending on the severity of the condition being monitored.

Rule 4: Devices intended for near-patient testing or self-testing are typically classified as Class B or C, depending on their criticality and the information they provide.

Rule 5: The following devices are classified as Class A:

• products for general laboratory use, accessories that possess no critical characteristics;
• instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;
• specimen receptacles.

Rule 6: Devices not covered by the above-mentioned classification rules are classified as Class B.

Rule 7: Devices that are controls without a quantitative or qualitative assigned value are classified as Class B.

 Similarities and differences with the MDR 

If you already have a medical device product certified under the MDR, you’ll discover many similarities with the IVDR. Like the MDR, your first step is to define the intended use of the product, and then determine its risk class based on the rules above. 

From there, it’s a case of locating the relevant requirements within the IVDR. As with the MDR, you need to compile a technical file, perform thorough risk management on your device, control the entire lifecycle, and conduct Post Market Surveillance (PMS). 

The biggest difference between the MDR and IVDR is the focus on patient safety. With the MDR, patient safety is imperative, so clinical evaluation takes center stage. On the other hand, as IVDs don’t directly impact a patient’s health, the focus is on testing accuracy. Other than that, most of the requirements set out by the MDR and IVDR are like for like. 

Both types of product require a unique device identifier (UDI), and both need PMS plans in place to monitor performance on the market. There’s more good news for companies with a medical device product on the market because if you have a Quality Management System (QMS) and ISO 13485 – you can apply them to IVDs as well.  

Like the MDR, after the IVDR was adopted in 2017, it soon became apparent that many manufacturers would be unable to meet the deadline for compliance. Initially, the IVDR was set to be fully implemented by May 2022, but recognizing the challenges faced by the industry – particularly in light of the COVID-19 pandemic and the complexities of transitioning from the In Vitro Device Directive (IVDD) – the European Commission introduced staggered deadlines. 

The staggered deadlines apply to companies who wish to continue marketing their existing catalog of IVD products to the European market. Under this amendment, the revised deadlines are as follows:

To take advantage of these extended timelines, and facilitate the IVDR transition, manufacturers must continue to comply with the IVDD and establish a QMS by May 26, 2025. 

Manufacturers must adhere to post-market requirements, which apply to all devices, with a Notified Body assuming surveillance responsibility once an agreement is in place. Clinical performance and post-market follow-up studies have to meet Annex XIII and XIV standards. On top of that, manufacturers are required to notify Competent Authorities and health institutions six months before any supply interruptions that could pose serious risks to patients. 

One significant upside to addressing the regulatory burden of both the MDR and the IVDR is that compliance ultimately leads to better, safer products. In a competitive marketplace, it also differentiates your product from those that only have approval under the previous, less stringent, outgoing regulations.

Specialist support with the IVDR 

Here at Peercode Regulatory Consultancy, we’re experts in helping companies get their medical devices certified for the EU market. In fact, all the lessons we’ve learned from certification under the MDR – including our own range of Software as a Medical Device (SaMD) products – also apply to the IVDR. 

No matter where you are on your product journey – from concept to production – using our experience and expertise, we can walk you through the entire compliance journey from start to finish, supporting you with a range of regulatory challenges, including:

• defining your product’s intended use and classification
• identifying and preparing the right technical documents
• setting up a QMS for IVDs
   

Let Peercode Regulatory Consultancy guide you through the regulatory labyrinth of the EU legislation for medical products. Speak to one of our experts today. Contact us