Device Classification And Device Grouping
As we have mentioned in our Ultimate Guide for Regulatory Affairs in Colombia, INVIMA (the National Institute of Vigilance of Food and Medicines) is in charge of assuring that the products distributed in Colombia, including Medical Devices, Biomedical Equipment and IVDs, are in full compliance with the requirements for safety and performance.
That being said, it is anticipated that every medical device has an inherent risk to the patients depending on a series of factors, including the level of invasion to the body, the intended use and the technology applied on the device. For Biomedical Equipment, such level of risk is differentiated by its device classification.
Classification
In Colombia, medical devices can be located in one of the next four classes: Class I, Class IIa, Class IIb and Class III for low risk, medium risk, high risk and very high risk, respectively. On the other hand, the IVDs are also divided in three different categories, starting with the Category III for high risk, Category II for medium risk and Category I for low risk, depending on the technology and impact of their respective results.
The tables below include examples of every class or category:
Medical devices and biomedical equipment
Description
Low risk devices, not intended to protect or maintain life and its use does not represent a risk for illness or injury.
Example
Surgical instruments, sterile gauzes, cotton and non-needled syringes.
Description
Moderate risk devices, subject to special controls during the manufacturing stage to demonstrate safety and efficacy.
Example
Hypodermic needles, intravenous catheters, ultrasound systems and suction equipment.
Description
High risk devices, subject to special controls during the design and manufacturing stages to demonstrate safety and efficacy.
Example
Lung ventilators, stents, blood bags, defibrillators and orthopedic implants.
Description
Very high-risk devices, intended to protect or maintain life and/or its use represents a potential risk of illness or injury.
Example
Pacemakers, heart valves and dermal fillers.
In Vitro Diagnostic devices
Used for crucial purposes
Used for screening donations of blood or organs, and to diagnose high risk contagious diseases, including rapid tests.
Related to more specific areas
Used for screening donations of blood or organs, and to diagnose high risk contagious diseases, including rapid tests.
Description
High risk devices, subject to special controls during the design and manufacturing stages to demonstrate safety and efficacy.
Example
Lung ventilators, stents, blood bags, defibrillators and orthopedic implants.
It is worth mentioning that making a proper classification of a medical device impacts not only on being conscious of the risk to patients and users, but also on the registration route to follow and the requirements to have these products approved by INVIMA. For further details, please read our Ultimate Guideline of Regulatory Affairs in Colombia.
According to article 6 of Decree 4725 of 2005, the classification is based on the following specific criteria:
- Separate devices of a system will be independently evaluated.
- Software will receive the same classification of the equipment it works with.
- If a device is meant to be used in different applications, the class will depend upon the riskiest one.
- When two or more classification rules applies, the highest classification must be considered.
Similarly, article 7 of the same regulation provides a list of 18 classification rules, presented in 4 chapters:
- Non-invasive medical devices
- Invasive medical devices
- Additional rules applicable to active medical devices
- Special rules
On the other hand, article 4 of the Decree 3770 of 2004 enlists 4 rules to classify the In Vitro Diagnostic products, which in general terms locates all these devices in two main groups: IVDs related to transmissible agents and non-related to transmissible agents.
In case any person or company is hesitant about a device classification, INVIMA is open to receive and attend written consultations.
Grouping
Another important topic to discuss is about the grouping of medical devices. This makes reference to all the individual components of a family or system that can be included in a single registration. Based on article 28 of the the Decree 4725 of 2005, a group of medical devices might be grouped in the same registration, as long as they share:
- The same device classification, have the same intended use and generic name, and are manufactured by the same company.
Differences regarding the size and any other aspect not impacting the intended use of the device, or those individual products that compose a kit or system, are accepted to be included in a single registration.
A relevant situation regarding the grouping criteria in Colombia is that different materials for a specific device do not cause independent registrations. This prevails, as long as those materials prove to be biocompatible using the applicable test reports.
As mentioned, INVIMA has identified that different medical devices by themselves can be registered in a KIT, if every component has been authorized previously. On the other hand, some products can be registered as a SYSTEM, if any of those products does not have a medical function by itself, but they have a medical intended use when working together.
We really hope you find this guideline useful and in case you have any further specific question, please contact us at contact@veraqueconsulting.com
Useful references
- Decree 3770 of 2004
- Decree 4725 of 2005
- ABC of Medical devices, by INVIMA
- INVIMA web page