What is a medical device?

What is a medical device?

In order to understand the classification of medical devices, one must first understand what is meant by the term ‘medical device’. A medical device is any instrument, apparatus, equipment, software or material used for the diagnosis, prevention, monitoring, treatment or alleviation of a disease, injury or disability.

Why categorise them?

European Regulation 2017/745 sets out the rules governing the placing on the market, marketing and putting into service of medical devices. The previous regulation defines the requirements that medical devices must meet according to their class: I, II or III.
Classifying medical devices allows for:
Assess the impact they will have on people’s health based on their contact with the human body.
Develop and implement ISO 13485 for medical devices.
Understand the procedures and requirements necessary to market the products.
At EmasConsultors, we help you achieve ISO 13485 certification regardless of your medical device’s class, by implementing the necessary requirements.

Categories of medical devices

Class I

These are products that pose the lowest risk to the user, as they are non-invasive and do not interact directly with the human body (e.g. diagnostic equipment, wheelchairs and even some software devices). It should be noted that a Class I device does not require a notified body to be placed on the market.

A notified body is an organisation designated by an EU country to establish the conformity of medical devices before they are placed on the market.

However, there are exceptions within Class I that do require a notified body in order to be placed on the market:

  • Class Is: sterile products (e.g. wound dressings)
  • Class Ir: reusable products (e.g. surgical equipment)
  • Class Im: reusable products (e.g. surgical equipment)

Class II

This covers low- to medium-risk medical devices. They can be divided into two distinct categories: IIa and IIb.

  • IIa: devices intended for short-term use, placed inside the body for a period ranging from 60 minutes to 30 days (e.g. hearing aids, catheters and contact lenses). The requirements include technical documentation and a declaration of conformity issued by a notified body.
  • IIb: products classified as medium to high risk, placed in the body for periods exceeding 30 days (e.g. ventilators and infusion pumps). In addition to the requirements for Class IIa, Class IIb products must undergo a ‘type examination by a notified body’ before being placed on the market.

Class III

Due to their potential to cause serious harm to the body, Class III devices are the highest risk (e.g. pacemakers, heart valves and balloon catheters). In addition to the requirements for Class IIb, Class III devices must have a quality system in place, along with a review of the device’s design and the device itself by a notified body.