Medical Device Classification

Medical device classification is a graduated system of controlling whether a medical device conforms to regulatory framework demands. The level of control corresponds to the level of potential hazard the specific type of device may present to the consumer or patient.

Medical device classification is part of the rules that national medical regulatory agencies set up for product types. What to keep in mind at the early stages of developing a medical device?

  • Determine the classification; a medical device manufacturer should determine the classification of his product as early as possible in medical device development, to have fewer problems later at the product certification stage.
  • Choose the correct type; choosing the proper medical device type is essential and may depend on the target market.
  • Check the definition with your regulatory agency; each regulatory agency defines its classifications for medical devices, although they are broadly comparable and similar. Nevertheless, a manufacturer has to acquaint himself with the exact wording applicable regulations of all the countries where he intends to sell.

Which are medical device regulators?

Do not forget that the rules for medical device classification differ between national regulators. When you decide to develop a medical device, we advise checking medical device regulations in all the markets where you plan to sell your device in the future. Some regulatory agencies from around the world:

  • Australia: the Therapeutic Goods Administration (TGA);
  • China: the National Medical Products Administration (NMPA);
  • Europe: the European Commission (EC);
  • Japan: the Pharmaceuticals and Medical Devices Agency (PMDA);
  • Russia: the Federal Service for Surveillance in Healthcare (Roszdravnadzor);
  • South Korea: the Ministry of Food and Drug Safety (MFDS);
  • United Kingdom: the Medicines and Healthcare Products Regulatory Agency (MHRA);
  • USA: the Food and Drug Administration (FDA).

On what is the classification of medical devices based?

Regulators base the classification of medical devices on the evaluation of potential risks that the utilisation of the medical device may pose to human health. The level of classification is, as a general rule, related to the perceived risk of the product type. Various criteria control the classification rules.

For example, in the EU these are intended purpose, the duration of contact with the patient, the degree of invasiveness and the part of the body affected by device use.

At the FDA, the Intended Use declares the general function of the medical device. In contrast, the Indications for Use define the condition the medical device will treat, diagnose and cure – and the target patient population. Usually, national agencies, i.g. in the US and EU, define Class I, Class II, or Class III devices, with the latter representing the highest-risk medical devices.

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