In order to determine whether your standalone software is considered to be a medical device it must first be determined what type of operating software is to be used. For example, is your software online software that runs through an internet browser, standalone software that operates without internet connection, or a program running separate from all computer processes.
According to the guidance document of the Medical Devices Directive 93/42/EEC Meddev 2.1/6 ‘ Guidelines on the Qualification and Classification of Stand Alone Software Used in Healthcare Within the Regulatory Framework of Medical Devices’ it must be determined what type of software (incorporated in the medical device or standalone) will be brought onto the market. When the software is not standalone and is directly part of a medical device, then the conformity assessment of the software is covered by the conformity assessment of the medical device in which the software is incorporated.
Further, it must be determined whether the standalone software falls within the scope of a medical device in accordance with article 1.2a of the Medical Device Directive 93/42/EEC. According to the aforementioned article, a medical device is defined as follows.
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be
used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings.
If the software cannot be defined as a medical device it could still be subjected to the Medical Device Directive as the software could be an accessory. An accessory is, according to the Medical Device Directive, defined as follows.
‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
When your software is subjected to the Medical Device Directive, it then also needs to be classified as a medical device. Annex IX of the Medical Device Directive indicates the classification criteria of medical devices. As software is categorized as an active medical device the classification rules 9, 10, 11 or 12 may be applicable to the software. Dependent on the intended use of the software it could be classified as a class I, IIa or IIb medical device.
Once the classification has been determined it is clear which conformity assessment procedure is applicable for the software. Table I indicates which conformity assessment procedure should be followed per medical device class.
Table I: conformity assessment procedure
|Medical device class||Conformity assessment procedure (Medical Device Directive 93/42/EEC)|
|IIa||Annex VII + Annex IV; or
Annex VII + Annex V; or
Annex VII + Annex VI; or
|IIb||Annex II; or
Annex III + Annex IV; or
Annex III + Annex V; or
Annex III + Annex VI
When the software is classified as a class IIa or IIb medical device a Notified Body must be used for the quality management system and an evaluation of the technical documentation. For class I medical devices evaluation by a notified body is not required.
The officially recognized quality management system under the Medical Device Directive is the harmonized standard ISO 13485 “ Medical devices – Quality management systems – Requirements for regulatory purposes”.
A technical file must be compiled in compliance with the Medical Device Directive based on the chosen conformity assessment procedure. This technical file will include proof that the stand alone software is in compliance with the essential requirements as indicated in the Medical Device Directive.
Once all procedures are in compliance and conformity has been established that the Medical Device and the standalone software is in compliance with the Medical Device Directive, an official Declaration of Conformity can be compiled and the CE mark can be applied to the medical device.
Disclaimer: Information is a based on the EU Medical Device Directive.