The In Vitro Diagnostic Regulation has held the center of the medical device manufacturers’ community’s attention for a while now. While most manufacturers know of it, many details can still be confusing. Here are the most asked questions about IVDR and their answers.
What is IVDR?
Simply put, IVDR is the new rule that will require all medical devices intended to be used on testing samples from inside a human body to pass a series of requirements before they’re allowed to be marketed. The IVD Regulation, as it’s called, is meant to protect patients from medical devices that might not have undergone sufficient testing before they’re released onto the market. As a result, it has broad implications for the medical device industry.
IVDR is a European regulation that governs the commercialization of in vitro diagnostic medical devices. It is intended to ensure that these devices are safe for use and that their accuracy is reliable.
What is an IVD?
According to the European Union official webpage, “There is a broad range of in vitro diagnostics (IVDs), from self-tests for pregnancy and blood glucose tests for diabetics, to sophisticated diagnoses performed in clinical laboratories. Other examples of IVDs are HIV tests or COVID-19 tests.”
What does “In vitro” mean?
“In vitro” is derived from Latin and means “in the glass.” In biology, it refers to experimentation that is done outside of a living organism, usually on a cell, tissue, or organ. For example, an IVD device is a tool used to examine specimens taken from your body. These devices range from simple test strips to complex medical machinery, from blood glucose monitors to allergy testing machines.
In vitro Diagnostics products are required by law for the EU to show that they conform to the current regulation on In vitro Diagnostic Devices.
What is the difference between IVDD and IVDR?
IVDD was the previously used directive related to in vitro medical devices. However, these were constructed in the 1990s, making them unfit for the current devices and technology.
The IVDR is a directive that came into force in 2017 to replace the IVDD, passed in the 2000s.
The point to be noted is that the IVDR and the IVDD are pretty similar but not identical. For example, the IVDR (In Vitro Diagnostic Medical Devices Regulation) and the IVDD (In Vitro Diagnostic Devices Directive) are similar in that they’re both regulations and affect the manufacturers and products to some extent. They share many of the same requirements; however, the IVDR adds a few new ones that make it different from the IVDD.
Comparative with the IVDD, the IVDR emphasizes product life cycle management and continuous product evaluations. In addition, the IVDR demands that the manufacturers demonstrate the implementation of effective quality control procedures.
The most notable difference between IVDD and IVDR is the device classification. In IVDD, in vitro diagnostic (IVD) devices were primarily considered low-risk. However, according to the IVDR, they are considered in different categories, from low-to-moderate risk to high risk.
The IVDR classification determines the level of supervision and assessment required for each product. According to the EU, at least 85% of IVDs will need notified bodies’ involvement. In addition, for higher-risk devices (class D devices), the involvement of the EU Reference Laboratory will be required.
Another notable change in the IVDR regarding in vitro medical devices is the increased involvement of the notified bodies and the regulations regarding economic operators.
Complemented by the new MDR and EUDAMED support, IVDR will promote a higher level of transparency than its predecessor.
What is the difference between IVDR and MDR?
The EU IVDR is part of the broader EU Medical Device Regulations (MDR). The IVDR contains rules for specific devices, including IVD reagents and devices that are intended to be delivered into a body.
The IVDR also includes rules for device vigilance, which is an important part of the MDR. It is also aimed at preventing incidents from occurring as well as minimizing their severity. The IVDR regulates the design and manufacturing of in vitro diagnostic medical devices, including in vitro diagnostics for human use. The MDR requirements are based on the risks inherent to each type of device.
Key components of IVDR compliance
IVDR has clear and concise requirements from each person responsible, from the ideation to the launch of the device.
For manufacturers, according to the EU, the responsibilities include:
- Manufacturers shall have systems for risk management (According to Article 10)
- They should have a quality management system.
- They are required to conduct performance evaluations
- They are required to gather and update technical documentation.
- They need to apply a conformity assessment procedure.
- They are responsible for the devices and are expected to: take corrective actions, record/ report incidents, and submit evidence of conformity to authorities.
- They are to have financial responsibility system and a designated person responsible for regulatory compliance.
How to categorize your in vitro diagnostic device under the IVDR
As with EU MDRs, IVDRs are grouped instruments within four regulation groups, with high-risk Class A IVDs equivalent to the Class 1 medical devices in the MDRs and the like.
For a device to be certified, it has to have proven:
- scientific validity
- analytical performance; and,
- clinical performance
The conformity assessment will be done along these lines. You have to contact your notified body (and ensure they are notified under the new regulation) and plan out the certification submission depending on their availability.
When does the IVDR come into effect?
From as of 26 May 2022, actually. However, you still have time because the EU stated that all certificates given under the IVDD are valid until 26 May 2024.
Nevertheless, IVDR certification is a long process, requiring time before and after the submission of necessary documents. So, if you haven’t already, better get started!
- Factsheet for Manufacturers of in vitro diagnostic medical devices.