A lot has been said and written already about the new Medical Device Regulation (MDR) which is now just around the corner (a little bit more than one year left to get ready).
One of the aspects that will change are the classification rules. Although the impact on the industry might be more significant for the In-Vitro Diagnostics, also within the Medical Devices, there are significant differences.
Let's focus on one rule that potentially will have a big impact on software manufacturers: Rule 11
First things first...
How is software currently classified under the 93/42/EEC Medical Device Directive?
What is the actual definition of a medical device under the Medical Device Directive (MDD)?
Article 1, §2.a says the following:
‘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 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, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
This means that software that is used for the above purpose is considered to be a medical device.
Annex IX, paragraph 2.3 of the MDD says:
Software, which drives a device or influences the use of a device, falls automatically in the same class.
This means that when your software is part of or an accessory to a medical device, it takes the same classification as that device.
For stand-alone software, we can find the following in Annex IX, paragraph 1.4 of the MDD:
Active medical device: Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand-alone software is considered to be an active medical device.
This means we should consider the classification rules for active medical devices when it comes to stand-alone software. These are rules 9 to 12 which lead to a possible classification from Class I up to Class IIb.
What is changing in the 2017/745 Medical Device Regulation?
There are major differences for stand-alone software.
Stand-alone software is still considered an active device, but the MDR contains a specific (new) rule related to stand-alone software, this being rule 11:
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
— death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
— a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
The first obvious difference is that now stand-alone software can be anywhere from Class I up to Class III instead of IIb.
Some software classification will be very different.
For example a software that is used to select and/or calculate a dose of a cytostatic drug will go from Class I to Class III.
A further example is an app that scans and analyzes moles and gives a probability of the scanned mole being a melanoma goes from Class I to at least Class IIb.
What does that mean for the manufacturers?
Being catapulted from Class I to Class IIb or Class III has a very major impact on every aspect of a device.
1. The development time is increased because of the additional requirements with regards to tests that need to be performed.
2. Documentation requirements are a lot stricter. So this requires a more complex and exhaustive Technical File which then needs to be reviewed and certified by a Notified Body.
3. The organization is required to implement a full Quality Management System.
All of the above will dramatically increase the time-to-market.
It has to be considered that the creation of and changes to the software will need to go through a much stricter and more elaborate development process.
To give you an idea on the impact in time and resources required, please refer to these regulatory charts by Emergo Group.
We started by saying the MDR is just around the corner and this is true for everyone. Your first task is to understand the impact on your product and its classification.
So it is critical to review your intended use and purpose and see in which classification your software will end up!