Classification of Medical Devices
In the context of medical devices there are different classifications that should not be confused:
- The classification, whether or not the product is a medical device
- The classification of the medical device according to medical device directive respectively medical device regulation, i.e. I, IIa, IIb, and III
- Software safety classification according to IEC 62304
Classification 1: Medical or non-medical device
Definition of Medical Device
A product is a medical device if and only if it meets the definition of a medical device in accordance with the medical device directive or medical device regulation:
Definition: Medical Device
„Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- the investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.“
Consequences of classification as a medical device
This definition has the following consequence:
- Not the functionality of the product is decisive but the intended use by the manufacturer. E.g. a DICOM viewer (a stand-alone software to view radiology images) is a medical device if the manufacturer intents the product to be used for diagnostic radiology. It is not a medical device if the manufacturer intents the product to be used to verify whether images have been taken e.g. to check reimbursement.
- It is irrelevant whether the manufacturer classifies the product as a medical device or not. Just the intended use is decisive.
Especially in software, there are always borderline cases.
Read our article on the classification of software as a medical device.
Any medical device (and any accessory) has to fulfill the regulatory requirements as laid down in the Medical Device Directive respectively Medical Device Regulation and the national laws e.g.:
- Manufacturers have to compile technical documentation (“technical file”)
- Manufacturers have to classify the product (see below)
- Manufacturers have to prove compliance with the essential requirements by following a conformity assessment procedure
- Manufacturers have to affix a CE-marking and a Unique Device Identification on the devices
- Manufacturers (typically) have to establish a quality management system and for non-class-I-products to certify this QM system.
Classification 2: Classes according to the Medical Device Directive
The Medical Device Directive lists the classification rules in Appendix IX, which states that the medical products fall into one of the following classifications:
- Class I
- Class I *, where * either stands for “with measuring function” or for “sterile”
- Class IIa
- Class IIb
- Class III
In our e-learning library, you get to know the classification rules. The training videos also tell you, how the classification of medical products affects the available range of conformity assessment procedures.
The Medical Device Regulation sticks with these classes, however, the conformity assessment procedures slightly have been changed, as well as the classification criteria, in particular the software-specific.
Classification 3: Software Safety Classes according to IEC 62304
The IEC 62304 is a harmonized standard that also is recognized by the FDA. The IEC 62304 defines three software safety classes:
- Class A: If the software cannot cause any harm
- Class B: If the software can cause minor harm such as injuries
- Class C: If the software can cause major harm such as severe injuries or even death
The software safety class determines the amount and granularity of required software documentation.