How are medical devices categorized by potential risk class?

In earlier articles, we have repeatedly mentioned that expert examination during registration is carried out within different timeframes. This is primarily because the safety class for the use of a medical product has been determined. The rules apply to both equipment and products for in-vitro diagnostics. Even software that represents an MI. The current risk classification of medical devices is regulated by the EAEU rules (Decision 173), as well as national rules harmonized with them (Order 281/2020). 

How is the safety category of medical devices determined and why is it needed? All products are different. Some are used to deliver fluids into or out of the body. Others are used to collect and analyze biomaterial. Still others correct vision, and others don't even come in contact with humans. Those that are invasive must be sterile, those that don't touch humans must meet other requirements. And so on. Each needs a different approach to testing and evaluation. To determine the most general criteria for assessing the impact on the human body, they were divided into 4 groups. These groups determine the class of potential risk of a medical device. 

Expertise

To everyone involved in the registration process (lcs-kz), just the risk class of medical devices tells us a lot. We may not even know what kind of product it is, but if we know that it belongs to 2b or 3, we immediately realize that this means longer terms and higher requirements. If the site is new, these types of product immediately tell us that there will be an audit by the regulator. Or that clinical trials will be requested for these products. There are many examples of determining the list of required documents by species. The same is true for experts. For elevated categories, there is increased scrutiny. Because these products carry the highest potential threat to humans.

During registration, depending on the group, examiners may request additional data not stated in the list. For example, for sterile MI, a validation report on the sterilization process is requested. If a product may be subjected to different sterilization methods, say ethylene oxide and radiation, a report for only one method will not be sufficient. The experts will request reports for both methods of sterilization. And there are many such nuances. 
Thus, it can be clearly seen that medical device registration is conducted based on the type of security. This affects the timeframe, procedures and the list of documents required to be submitted.

Regulation 

The regulations define the division by hazard of use based on the functional purpose and conditions. The duration of contact, invasiveness, type of delivery, and which organ or system the product is intended for are also taken into account. The regulations separate the sorting method for IVDs because they have their own specifics. But in general, 1, 2a, 2b and 3 are the designations used for EAEU and CIS countries. Similar designation is also used by Europe and many countries of the world, with a few exceptions.         

Each medical device is assigned only one safety class for its use. However, it happens that due to differences in regulation in different countries, the same MI may belong to different safety groups, according to the rules of regulation of these countries. During registration, such a dossier will be examined according to the rules in force in the country of registration. But if the class is overrated in the producer's country, the country conducting the registration will evaluate the product according to the overrated order. 

Features

Medical device potential risk class 2a has one interesting feature. If the MI of this type is sterile, the manufacturing site will be audited. If it is non-sterile, it will not. This is because it is mandatory for a manufacturer of sterile products to have an ISO 13485 certificate. And the site is audited for compliance with the requirements of this ISO. 

It is worth noting that the potential risk class of medical device 1 is also assigned to sterile products falling under this category. And for such samples (for example, sterile bandages) it is also mandatory to have ISO 13485. This is also required by the list of dossier documents. However, when it comes to in vitro diagnostics, outside of type, this certificate is mandatory. 

The appropriate type is assigned to kits or systems according to the highest class in the composition. For example, the technique itself may be 2a, but if there are items or reagents in the composition that are 2b, the entire application will be assigned 2b. This rule also applies to IVDs, whether they are "open" or "closed" systems.