Wearables collecting health data might significantly change due to two newly adopted European regulations.
In the market of medical devices the exploration of wearable technologies is growing at a rapid pace and regulation needs to adapt accordingly.
Also to meet this need, on 5 April 2017 two new EU regulations on medical devices have been adopted:
- Regulation (EU) 2017/745 on medical devices (“MDR“), and
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR“)
Both Regulations have been published a few days ago on the Official Journal of the European Union (available here).
The new Regulations “will help to ensure that all medical devices – from heart valves to sticking plasters to artificial hips – are safe and perform well”, the European Commission stated in a press release.
They will provide significant changes in the concerned sector and they will have an impact also on wearable technology in medical devices.
- Software classification
Directive 2007/47/EC (amending Directive 90/385/EEC and Directive 93/42/EEC concerning, respectively, active implantable medical devices and medical devices) already clarified that software, when specifically intended by the manufacturer to be used for one or more of the medical purposes is a medical device, whilst software for general purposes when used in a healthcare setting is not a medical device.
Medical purposes are
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or a disability,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception.
MDR goes further and specifies that software shall also be deemed to be an “active device”, i.e. “any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy“.
MDR also provides rules for software classification as medical devices. The classification of medical devices is a progressive risk-based system taking into account the potential risks associated with the devices.
Under MDR, software are generally in class I, i.e. less critical devices.
However, software which provides information used to take diagnostic / therapeutic decisions is in class IIa, except if such decisions can have a serious impact on patient health, in which case the classification will be class III or IIb; software intended to monitor physiological processes is in class IIa, except if intended to monitor vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, in which case it is in class IIb.
Depending on classification, software medical devices are subject to stricter safety rules and conformity assessment.
- Wider definition of “accessories”
MDR broadens the scope of the definition of “accessories” including articles which, whilst not being themselves medical devices, are intended by their manufacturer to specifically and directly assist the medical functionality other medical devices in their intended purpose.
Accessories shall be treated as medical devices in their own right.
Software may therefore qualify either as a device or an accessory, with the consequence of being subject to the rules set forth by MDR.
- Next steps
MDR and IVDR shall enter into force on the twentieth day after their publication in the Official Journal of the European Union and will be applicable, respectively, in three and five years. So no immediate actions are required for manufacturers and supply chain operators. However, changes are significant and manufacturers and other participants in the supply chain should be aware as of now of the new rules and their respective responsibilities in order to be able to adapt in time.