Software - As A Medical Device
In accordance with MDR 2017/745 and IVDR 2017/746, software used as a medical device must be given special consideration and classified according to rule 11 out of the classification rules in Chapter V of MDR 2017/745.
However, in the UK, standalone software and apps that meet the definition of a medical device
are still required to be UKCA marked in line with the Medical Device Regulations 2002 (as
amended) (UK MDR 2002) in order to ensure they are regulated and acceptably safe to use and
also perform in the way the manufacturer/ developer intends them to.
Classification of Software as Medical Device
Implementing rule 2.3 -Software, which drives a device or influences the use of a device automatically falls into the classification of that device.
Rule 9 -All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb. All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb.·
Rule 10 -Active devices intended for diagnosis are in Class IIa:—if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient’s body, in the visible spectrum,—if they are intended to image in vivo distribution of radiopharmaceuticals,—if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb.·
Rule 12 -All other active devices are class I.·
Rule 14 -All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in class IIb.
While compliance of class I devices is based on self-declaration by the manufacturer, all other UKCA marked devices require use of an UK approved body to assess compliance (if the device is CE marked, an EU NB will be needed).All devices placed on the Great Britain market must be registered with MHRA. Clinical data is required for all medical devices and for some novel software clinical investigations may be needed.
All activities related to the validation and modification of IEC62304:2016 software as a medical device must be monitored and documented throughout its lifecycle.
Our team of experienced regulatory and quality professionals will help your organisation set up a Quality Management System that meets the requirements of ISO 13485: 2016, as well as create technical files in accordance with MDR 2017/745, IVDR 2017/746, UKCA.
For further details, please Contact Us