Medical devices are devices whose purpose is to benefit patients. They are usually used by doctors and healthcare providers to help them diagnose and treat patients. Despite its usefulness, they can pose a potential risk for human health. Therefore, they must be proved safe and effective.
Medical devices Class I are generally not implantable invasive devices. These devices can’t sustain human life. They would be for example band-aids, simple wound dressings, wheelchairs, etc.
Numerous regulatory bodies are monitoring the marketing of medical devices. A medical device classification system is therefore needed, to apply to medical devices an appropriate conformity assessment procedure. In this article, we will mention how the US and the EU classify medical devices concerning medical device class I.
Medical devices class I in the EU
Medical Device Regulation (MDR) divides medical devices into four classes: Class I, IIa, IIb, and III, where class I devices are seen as the lowest risk, whereas Class III are considered as high-risk devices. So, medical device Class I are the ones with the lowest to moderate risk to patient health and safety.
Medical device manufacturers have to follow conformity assessment procedures before placing a device on the market. By following it, they are proving compliance with the device established by MDR.
Steps for Class I medical devices compliance
- Classification: ensure the device is a Class I medical device
- Choose Conformity Assessment Route
- Compile the Technical File
- Declaration of Conformity
- Appoint an Authorized Representative
- Vigilance and Post Market Surveillance
Conformity to the International and European Standard EN ISO 13485 is voluntary.
*Conformity assessment route for medical device class I
- The medical device manufacturer is responsible for ensuring that their product complies with all the relevant General Safety and Performance Requirements and must draw up a written statement to this effect (self-declaration).
- Class I medical device without a measuring function and supplied in non-sterile conditions does not require the involvement of NB.
- Manufacturers of sterile products and devices with a measuring function must apply to an NB for certification of the aspects of manufacture relating to sterility or metrology.
- Once the manufacturer is satisfied that their products meet all the relevant Essential Requirements, the manufacturer, or appointed European Authorized Representative (if the manufacturer is located outside of EEA), must register with the Competent Authority (CA). The manufacturer may then affix the CE marking on the products and place them on the EEA market.
Medical devices class I in the US
In the US, the process functions slightly differently. FDA defines three regulatory controls for each medical device class: class I, class II, or class III. For medical devices Class I, that are considered to be low to moderate risk, it applies General Controls with and without exemptions. Classification is linked to the intended use and indication for use. Practically, they are explaining the reason for its existence.
General controls apply to all medical devices unless exempted by regulations. Most of Class I medical devices are exempt from premarket notification 510(k), but they still have to comply with other requirements unless the device is specifically exempt from those requirements. To find out whether is device exempt from 510(k) it’s enough to enter the FDA’s Product Classification database.
Usually, devices that are exempted from 510(k) are amendments devices and those that are explicitly exempted by the FDA.
Key differences are that the FDA requires clinical trial data, and the CE mark can be obtained following usage and application of successful clinical evaluation of equivalent pre-existing devices and a subsequent post-market study.
Implementing a QMS leads to making a compliant device and far better outcome in the terms of obtaining the approval/clearance to place your device on the market, book your live demo today, and find out how