In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges

By Published On: October 17th, 2023Categories: IVDR, Latest Publications

All medical devices have their merit since all of them are used in the medical field. However, the In vitro diagnostic tools are especially essential since medical practitioners use them to identify, treat, and manage diseases.

IVD devices or In Vitro Diagnostic devices are devices that are used primarily for diagnosis. The “in vitro” word refers to the fact that these diagnostic tools are used outside of the body as opposed to “in vivo” diagnostic tests conducted on/in the body.
In vitro diagnostic medical devices conduct a wide range of tests. From simple blood-pressure measuring sphygmomanometers to cancer screening machines, all are considered in vitro diagnostic tools. Since, a lot of the time, the physician’s diagnosis and course of treatment depend on the results of these tests, quality regulation for in vitro diagnostic medical devices is very strict. Manufacturers of medical devices have to give absolute guarantees of the security and efficiency of these apparatuses.
As you can imagine, getting an IVD device approved by regulatory organizations is no easy feat either. Each section of the submission document is carefully assessed, checked, and then assessed some more. In today’s article, we talk about some of the obstacles to risk management you can expect to encounter while getting your IVD device ready for the market.

Complex IVDR Regulations

The intricacy of the regulations governing in vitro diagnostic equipment is one of the biggest obstacles manufacturers face. These devices are subject to stringent regulatory regulations, making the documentation and review process a bit more laborious.
According to the IVDR document, manufacturers have to “establish, implement, document, and maintain a risk management system.”
While they are not exactly specific about how and which risks to manage or avoid, the IVDR does give a list of stuff you should do.

The important ones are:

  • Creating a risk management plan
  • Identify and evaluate the known and expected risks specific to your device.
  • Predict and assess the risks that come with the intended use of the device, as well as the misuse that could happen;
  • Assess information from both the production and, especially, the post-market stages.
  • Have a surveillance system for risks and how often they happen, on estimation of the associated risks, total risk, the risk-benefit ratio, and the acceptable level of risk.
  • Get rid of or reduce risks as much as possible through safe design and production.
  • Take the right safety precautions for risks that you can’t eliminate.
  • Give users all safety information (warnings, precautions, and contra-indications) and, if needed, training.
  • Design the device focusing on patient safety.
  • Design keeping the end-users in mind (laymen, professionals, foreign nationals, disabled, etc.)
  • Keep in mind that: 
    • The characteristics and performance of the device will not deteriorate so much that it can harm a patient or a person handling it, given that the device is within its lifetime and under normal stresses.
    • The device has to be designed and packaged in a way that normal transportation and storage will not cause damage to its function. Sure, your device can be heat sensitive, but you have to mention it in the packaging and instructions explicitly. 
    • The benefits of using the device have to outweigh the risks. 

Not only do you have to have these steps in the documents you submit for your CE mark, but you are also legally responsible for ensuring your products meet all applicable regulatory standards. If your device falls into the higher risk category, working with an experienced regulatory consultant and being fully aware of all the regulations pertaining to in vitro diagnostic medical devices is often the best approach.

Risk Management Challenges of IVDR

From the above list, one thing is clear. Risk management is not a cut-and-dry list you can go through. Some of the regulations apply to almost all steps of manufacturing.

Managing the Product Life Cycle:

Compared to many other medical devices, in vitro diagnostic instruments have a longer life cycle. As a result, managing the product life cycle can provide serious challenges for manufacturers. While the product is still in the market, sure you have a risk management plan in place, one that addresses post-market issues like feedback monitoring, pre-market issues like design controls, and ongoing device upkeep and updating. And this has to be managed throughout a product’s life cycle.

Quality Control:

Comprehensive risk management protocols, documentation, and monitoring are essential components of an effective quality management system since they help prevent problems that could compromise the performance and safety of the equipment.

Technical Difficulties:

In vitro diagnostic medical devices are intricate items that include biomaterials, reagents, hardware, software, and other technologies. So, it’s not a stretch to assume that you might face technological difficulties. One way to overcome these obstacles is by assessing and minimizing technical risks earlier in the product development process. Plus, working with reliable vendors and other people in the supply chain who comprehend the technical facets of in vitro diagnostic instruments can be beneficial. That way, there is a lesser chance of mistakes.

Risks Associated with IVD

Not every In vitro diagnostic device is completely fail-safe. So, there is a significant risk of missing diagnoses, false negative results, or false positives. However, as a manufacturer, it’s your ethical and legal duty to ensure those don’t happen. For instance, if a patient got a false-negative test result, they could very likely receive the incorrect treatment or an inadequate medication dosage. You can imagine the legal repercussions you would have if this happened several times. The job of your risk management plan is to reduce the likelihood of any errors of this nature.

Product Updates and adjustments:

In order to comply with evolving tech and end-user demands, any medical devices, in vitro diagnostic devices not being exempt, have to undergo recurrent updates and adjustments. With each update and redesign, you have to control any risk factors that may arise. For example, with the addition of cloud storage and software to any in vitro diagnostic device, risk management must be redesigned, additional preventive and corrective plans drawn up, “notified bodies” notified, and associated changes must be added to the entire technical documentation. However, all of this is worth it cause it will guarantee the safety and efficacy of updated and modified products. And that’s what we are here for, folks!

Creating a new IVD device

Here’s the thing: risk management is mandatory in IVDR. So, if you are thinking of manufacturing and commercializing IVD devices, it depends heavily on having an efficient risk management system. However, there are a few perks of starting new, too. You can ensure your device holds up to new clinical evidence standards, make sure you have supply chain traceability, assign a unique device identification number, sort out the clinical investigations, etc. Do everything you can to ensure IVDR compliance based on the risk class of your in vitro medical device. Doing it right the first time saves you a lot of time and effort down the road.
Ensuring the safety and efficacy of in vitro diagnostic devices is not easy, but it’s a must-have. These devices are subject to strict regulatory restrictions since they substantially impact patients’ health. As a manufacturer, you must have a good quality management system, work with an experienced regulatory consultant, adhere to a well-drawn risk management plan, and be vigilant.

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