Device Classification

Question 1

What is meant by Class 1?

Answer 1

Generally regarded as low risk
The manufacturers of such devices can choose one out of three possible CE marking routes. In this regard, they should consider the following: if the medical device is sterile, e.g., a personal protection kit; if the medical device has measuring functions, e.g., stethoscope; and, if it’s not sterile, nor measuring, e.g., corrective glasses. If your product is class I, and it’s not a sterile or measuring device, then all you need to do is to self-certificate it, and formally declare its compliance with the applicable requirements of the MDD via a written statement. If it’s a sterile or a measuring medical device, then you will need a Notified body assessment.

Question 2

What is meant by Class 2a?

Answer 2

Generally regarded as medium risk 
•	Medical devices of class IIa could be such as surgical gloves, hearing aids, diagnostic ultrasound machines, etc. They usually constitute low to medium risk. Patients should use them for a short-term period, any less than 30 days. If you are a manufacturer of a class IIa medical device, you will have to back up your declaration of compliance with a Notified body assessment. Only then, you will be allowed to place your product on the market. There are four possible routes to CE mark your product, split into two groups given the product’s type, i.e., if it’s sterile or not.

Question 3

What is meant by Class 2b?

Answer 3

Generally regarded as medium risk
•	Here, we can include medical devices such as long-term corrective contact lenses, surgical lasers, defibrillators, and others. They are medium to high-risk devices, and patients may use them for a period longer than 30 days. In case your product is in class IIb, similar to the procedures in class IIa, you will need a Notified body to assess your technical documentation for compliance with the Medical Device Directive. The choice of a specific CE marking route will depend again on the type of your product.

Question 4

Class 1

Answer 4

Class I devices have minimal contact with patients and low impact on a patient’s overall health. In general, Class I devices do not come into contact with a patient’s internal organs, the central nervous system, or the cardiovascular system. These devices are subject to the fewest regulatory requirements.

Electric Toothbrush
Tongue Depressor
Oxygen Mask
Reusable Surgical Scalpel
Bandages
Hospital Beds
Non-electric wheelchair

The majority of Class I devices are exempt from FDA requirements for Premarket Notification (510k) and Premarket Approval (PMA).

Class I devices are not exempt from FDA general controls, a series of commands which applies to Class I, II, and III medical devices.

Question 5

Class 2

Answer 5

“devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”

Catheters
Blood Pressure Cuffs
Pregnancy Test Kits
Syringes
Blood Transfusion Kits
Contact Lenses
Surgical Gloves
Absorbable Sutures

The majority of Class II devices are FDA approved for the market through the Premarket Notification, or 510(k) process.