In the US, Center For Devices And Radiological Health (CDRH) which is a branch of FDA is the regulatory body that governs the rules and regulations for medical devices. It ensures the safety and smooth regulation of medical devices. Medical devices are divided into different categories and each of them requires different regulations which are overlooked by CDRH of FDA.
What Is A Class 1 Medical Device?
Class 1 Medical Devices often called “class 1 devices by FDA” are the devices that possess minimal risk and are associated with lowest regulatory requirements and controls.
Class 1 devices manufacturers do not require submitting pre-market notification and nor do they need to fulfill 21 CFR Part 820 requirements which the other two classes of medical devices require to follow.
How Does FDA Medical Devices Classified?
FDA has 1700 different categories for medical devices from where they are grouped into 16 categories and then assigned into one of the three categories of medical devices.
The reason why medical devices are classified into their respective categories is to determine the appropriate guidelines for the medical devices they are applicable to.
Regulatory Classification for Medical Devices (FDA & EU):
The regulatory bodies that is FDA in the US and EU in Europe classify the medical devices as follows:
Medical Device Classification By FDA:
Class I: Low risk and possess little to no harm to patients
FDA class 1 medical devices constitute 47% of the total medical devices.
Class 1 medical device regulations are:
Design and manufacturing controls
Quality system regulation
Labeling requirements
Post-market surveillance
Examples of Class 1 medical devices are: Scalpels, Most bandages, Oxygen masks, Bedpans, Latex gloves, Manual stethoscopes, etc.
Class II: Moderate risk to patient:
These devices constitute 43% of the total medical devices.
It must submit pre-market notification according to FDA’s 510(k) requirements.
The medical device should be substantially equivalent to the device already in market to categorize under class II medical device.
Examples of Class II medical devices are Blood pressure cuffs, Syringes, Pregnancy test kits, Infusion pumps, Oximeters, Blood transfusion kits.
Class III: High risk to patient:
These devices constitute 10% of the total medical devices.
These devices should follow the FDA’s general and special controls requirements.
Examples of Class III medical devices are Breast Implants, Pacemakers, Defibrillators, High-frequency ventilators, Cochlear implants, Fetal blood sampling monitors, Implanted prosthetics, etc.
To check and confirm under which category your medical device falls kindly visit the FDA official page.
EU Medical Devices Classification:
As per EU medical devices are classified as follows:
1. Class I Devices: These are low risk everyday use medical devices. Manufacturers require to issue the technical document for such devices.
Class Is Devices: Devices that require to be placed in sterile conditions in market These devices require technical documents as well as application to EU.
Class Im Devices: These are medical devices of class I with measuring function. Manufacturers here must be certified by the EU and must provide technical files.
Class Ir Devices: These are medical devices of class I for reusable surgical instruments. Manufacturers here must be certified by the EU and must provide technical files.
2. Class IIa Devices: These include low to moderate risk devices installed within the body in short term, that is between 30 mins to 60 days. Requirements for these medical devices are EU declaration of conformity, the technical documentation and a conformity assessment procedure carried out by an EU notified body according to Annex IX or Annex XI.
3. Class IIb Devices: These include slightly more complex medical devices as compared to class IIa devices. These are moderate to high-risk devices that are installed within the body for 30 days or longer. The regulatory requirements are the same as Class IIa with additional requirement of assessment of the technical documentation for every class IIb implantable device.
4. Class III Devices: This category involves high risk medical devices. The regulatory requirements for this category are EU declaration of conformity, the technical documentation and a conformity assessment procedure carried out by an EU according to Annex IX or Annex X coupled with Annex XI.
The classification of medical devices can be studied in more detail on our types of medical device blog.
What Exemptions Exists For Class I Medical Device?
As class I devices possess low risk, they are exempted from many regulatory requirements such as:
Premarket notification or PMA application for FDA
Manufacturing Processes (GMPs) for medical devices
activities under 21 CFR Part 820.
Regulatory Process For Class I Medical Devices:
Class I medical device regulations are according to EU that take place in 5 steps beginning from confirmation of medical device category to ending at EU registration. The steps that depict the class 1 medical device requirements are explained in the diagram below:
And the process according to FDA for MDR begins with the confirmation of medical device category and ending up with marketing approval and post marketing surveillance, which is explained below in the diagram:
So, with Artixio you can easily launch your medical device onto the market according to the regulatory requirements of the class in which your medical device fits well. So, check out at https://www.artixio.com/medical-devices for your achieving a successful medical device.
FAQ’s:
Is FDA approval required for Class 1 devices?
A: No, Class 1 medical devices do not require FDA approval as they are low risk devices.
Do Class I medical devices require premarket approval?
A: No, Class I medical devices do not require premarket approval.
Can medical devices of class I be sold in EU market?
A: Yes, medical devices of all classes can be sold in EU markets that comply with EU regulations.
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