By Marion Lepmets, CEO of SoftComply* & Tom Stamp, CEO of Blue Curve**
Following our article from last week on “Is My Software a Medical Device” to those of you who are now convinced that your software is indeed a duck (see the original article), then you are probably wondering “How do I get it approved for sale?”
Before you can place a medical device (including software that is a medical device, also known as SaMD) on the market, you need to demonstrate that you are compliant with national or regional regulations, and for most devices you also need approval for your medical device in that jurisdiction.
In this article we will focus on two regulatory markets – the US and the EU. In the US, the regulator for medical devices is the Food and Drug Administration. In the EU, the regulator is the European Commission.
For the EU, medical devices are currently regulated under one of the 3 EU directives:
Currently the EU is moving towards a more unified system of Medical Device Regulation, or MDR. This is a major change to the regulation of medical devices in the EU and will phase in over the next year (watch this space!).
So, how do we start figuring out which rules and approval paths apply for our medical device software in the US and EU? By classification, of course!
Medical Device Classifications in the US and the EU
Your medical device (including SaMD) classification determines the extent to which you have to comply with regulations and the rigor in which your medical device is going to be validated prior to market access in most regulatory regimes. The higher the risk imposed by your medical device to the patient or operator of the device, the more rigorous the development and the validation processes will be.
Both in the EU as well as in the US, the medical device classification is based on the intended use and the risk imposed to the patient, including the risk coming from clinical safety due to the duration of its contact with the body and the degree of invasiveness.
Based on the classification rules in Annex IX of the Medical Devices Directive (MDD) there are four main safety classes in the EU:
– Class I# – Low risk (e.g. tongue depressors)
– Class IIa – Low to Medium risk (e.g. hearing aids)
– Class IIb – Medium risk (e.g. respiration monitors)
– Class III – Highest risk (e.g. active implantable devices – pacemakers)
#There are several sub-classifications for Class I devices for the EU.
For Device Classification in the US, you can use the FDA Classification Database as a method to determine the class of your medical device by looking at the classification of predicate devices – devices that are similar to yours.
There are three safety classes for medical devices in the US:
– Class I – not intended to support or sustain human life (e.g. thermometer)
– Class II – could cause damage or harm to humans (e.g. powered wheelchairs)
– Class III – support or sustain human life (e.g. implantable pacemaker)
Once you have determined the medical device safety class, you will be able to pinpoint the corresponding path to market clearance based on the regulations. For most device classifications, the software will have to adhere to the same medical device regulations as a regular medical device. This will require, in part, a suitable Software Risk Management process, and in many cases the use of an approved Quality Management System. In order to kick-start your compliance initiative, SoftComply offers eQMS and Risk Manager.
In the next week’s blog, we will explain what regulations apply for which safety class and what are the requirements for design process and documentation.
Also coming soon – articles about design control, guidance documents for software in or as a medical device, international standards and risk assessment for software based medical devices…
* SoftComply is a developer of Cloud and Server based tools that help companies manage their software risks and implement their quality systems based on the medical device software regulations www.softcomply.com
** Blue Curve is a medical device engineering and safety consultancy company. www.bluecurve.com.au