Basics of the Medical Device Classification System
For many manufacturers in the industry, medical device classification can be a daunting task to say the least. Determining what device falls into what class, and what steps need to be taken afterwards to introduce the device to the European market can be difficult.
This blog will be a guide to the basics of the medical device classification system under the Medical Device Directive Annex IX and what restrictions exist at each class level.
- Class I Devices – Non-evasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids. Such devices require only for the manufacturer to complete a Technical File.
Class Is Devices – Class Is devices are similarly non-evasive devices, however this sub-group extends to include sterile devices. Examples of Class Is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. These devices also require a technical file, with the added requirement of an application to a European Notified Body for certification of manufacturing in conjunction with sterility standards.Class Is Devices – Class Is devices are similarly non-evasive devices, however this sub-group extends to include sterile devices. Examples of Class Is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. These devices also require a technical file, with the added requirement of an application to a European Notified Body for certification of manufacturing in conjunction with sterility standards.
- Class Im Devices – This refers chiefly to similarly low-risk measuring devices. Included in this category are: thermometers, droppers, and non-evasive blood pressure measuring devices. Once again the manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance with metrology regulations.
- Class IIa Devices – Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Examples include hearing-aids, blood transfusion tubes, and catheters. Requirements include technical files and a conformity test carried out by a European Notified Body.
- Class IIb Devices – Slightly more complex than IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment. Identical compliance route to Class IIa devices with an added requirement of a device type examination by a Notified Body.
- Class III Devices – Class III devices are strictly high risk devices. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. The steps to approval here include a full quality assurance system audit, along with examination of both the device’s design and the device itself by a European Notified Body.
While it can be stressful determining what class of device may need what set of certifications and approvals, the above guide is a useful reference point. However, it is always advisable to judge each case on its own merit, and is very often advisable to consult an Authorized Representative in instance of being unsure of local or cultural legislation. When in doubt, it is also valuable to consult the 18 Rules of Classification.
For more information on medical device classification services, or for how to appoint a European Authorized Representative, contact us today.