Many manufacturers, software developer, academics, clinicians and organisations are using software for both healthcare and social care needs.
This guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this seen to be part of the device, eg software that controls a CT scanner.
Key points and existing guidance
Software which has a medical purpose which at the time of it being placed onto the market is not incorporated into a medical device.
Regulation of medical devices is limited by the intended purpose as defined by the manufacturer. This will include claims given in promotional materials for the device, eg brochures and webpages.
Software that has a medical purpose could be a medical device. A medical device is defined in the medical device Directive (MDD) as:
“software… intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception….”
The other directive where this guidance is applicable is the active implantable medical device directive.
There is no definition of a system in the directive but there are specific requirements for products placed on the market that combine CE marked devices and non-CE marked products, eg a combination of laptop (not a medical device), software (a medical device) and heart monitoring hardware (an accessory) is considered to be a ‘system’ if these are placed on the market together.
In January 2012, the European Commission (EC) published a set of guidelines in MEDDEV 2.1/6 – Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices.
These guidelines will help you decide if your software is a medical device or an in vitro diagnostic. The following documents provide useful information to help software developers understand regulations for medical device software:
- European Commission MEDDEV 2.1/1 Definitions of “medical devices”, “accessory” and “manufacturer”
- European Commission Manual on borderline and classification in the Community Regulatory framework for medical devices
- Team NB FAQ on Implementation of EN 62304:2006 with respect to MDD 93/42/EEC.
- MHRA Borderlines with medical devices.