What is a medical device?

Medical Devices | Definition, categories and classification

Definition

Before applying for CE marking certification, a medical device manufacturer must identify the class of its medical device technology to establish the applicable requirements. Medical devices are described in article 2 of the Medical Devices Regulation (EU) 2017/745 as “instruments, apparatus, appliances, materials or other articles intended by the manufacturer to be used, alone or in combination, for human beings, for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of diseases, injuries or handicaps, replacement or modification of the anatomy or physiological processes.”

Ranging from simple protective devices such as disposable surgical masks or gloves, through small and large medical equipment to sophisticated high-tech and innovative medical device technologies such as electrosurgical robots and embedded or standalone software, medical devices are classified based on series of parameters, such as the intended use, risk or disease.

The medical device class can be determined using the classification rules laid out in Regulation (EU) 2017/745 or the European Directive applicable to medical device technology. Classification is determined based on the device’s intended use, characteristics and inherent risks. Identifying the medical device class will help determine the conformity assessment route or procedure that the medical device manufacturer will need to follow for their certification project.

Categories

Under the MDR, there 3 major categories for medical devices:

• Non-invasive devices (1-4);
• Invasive medical devices (5-8);
• Active medical devices (9-13);
• Special Rules (14-22).

Classification

Europe uses a rule-based system for the classification of medical devices. Like the MDD, the MDR has four main risk-based categories, starting with Class I (low risk), Class IIa (medium risk), Class IIb (medium/high risk) and ending with Class III (high risk). Under the Medical Device Directive 93/42/EEC (MDD), Annex IX outlines 18 classification rules and 56 criteria's.

While the rules' structure is maintained between the MDD and the MDR, the number of rules has changed. In Article 51, Annex VIII of the Medical Device Regulation EU 2017/745, there are now 22 classification rules and 80 criteria's used to determine a medical device classification.

The MDR also includes products listed in Annex XVI that were not regulated under the MDD. They didn't have an intended medical purpose (facial dermal fillers, coloured contact lenses, lasers for skin resurfacing, tattoo or hair removal etc.)

A comparison between the MDR and MDD classification

MDR (2017/745)

• 22 classification rules
• 80 criteria
• Class 1
• Class 1 measuring function
• Class 1 sterile
• Class 1 reusable surgical instrument
• Class IIa
• Class IIb
• Class IIb implantable
• Class III

MDD (93/42/EEC)

• 18 classification rules
• 56 criteria
• Class I
• Class I measuring function
• Class I sterile
• Class IIa
• Class IIb
• Class III

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