Terminology
In order to understand medical device regulation, it is important to understand the terms qualification and classification.
Qualification refers to determining whether a given device qualifies as a medical device, and if it does, whether it qualifies as a medical device, or as an in-vitro diagnostic (IVD) device. The latter refers to devices used to study biological samples, e.g. blood analysis devices. IVD devices are not governed by the EU Medical Device Regulation (MDR), rather they have their own IVD Regulation (IVDR).
Classification, on the other hand, refers to the risk classification of a medical device or IVD device. The higher the class of the device, the higher the risk, and the higher the requirements placed on the device manufacturer. Medical devices are officially classified into four risk classes – class I, class IIa, class IIb, and class III – but some of the classes have subclasses with a slightly different level of requirements. For example, class I devices that have a measuring function are treated differently by the regulation than “regular” class I devices (use of a Notified Body is required), and they are sometimes referred to as class Im devices. IVD devices, on the other hand, are classified as class A, class B, class C or class D devices.
MEDDEV 2.1/6 Guidance
Now, when considering the qualification and classification of remote patient monitoring systems, the authorative guidance for the old Medical Device Directive (MDD) is MEDDEV 2.1/6. However, it has not yet been updated for the MDR, although there are credible rumors that an update is expected before the end of the year.
The classification rules of MDR are substantially different from those in MDD, so it is reasonable to expect that classification guidance has changed accordingly. Specifically, remote patient monitoring systems were earlier typically classified as class I devices, but will now be classified as class IIa or class IIb devices due to rule 11 of the MDR:
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.
MDR Classification Rules
However, classification is only relevant if a device is considered a medical device in the first place. Whereas the classification rules have changed significantly between MDD and MDR, the definition of a medical device has not substantially changed with regard to monitoring of patients:
MDD
‘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;
MDD, definition of a medical device (emphasis added)
MDR
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
MDR, definition of a medical device (emphasis added)
Clearly monitoring of a disease, injury or disability is covered by both definitions. However, the regulators need to draw a line somewhere between medical IT systems and non-medical IT-systems used in healthcare, simply because it is not practical (nor useful) to require all healthcare IT systems to be certified as medical devices. That line is drawn by the MEDDEV 2.1/6 guidance. The latest version of the guidance is from 2016, so it is relatively recent. Given that MDR does not introduce any changes to the definition of a medical device that would justify changing how the line is drawn for remote patient monitoring systems, there is no reason to expect drastic changes. In fact, the Finnish regulatory authority Valvira has even said that the current MEDDEV 2.1/6 guidance can still be used to determine whether a software system is a medical device.
So, how does MEDDEV 2.1/6 draw the line? If your system contains only the following functionalities, it is not a medical device:
- Storage
- Archival
- Lossless compression
- Communication
- Simple search (search that only does “dumb” matching against given search criteria and does not include intrepretative search results)
- Simple display (implicit given the previous ones)
- However, e.g. display of images using image alteration techiques for the purpose of facilitating the medical use of the images, such as improving contrast, may make the software into a medical device
- Altering the representation for embellishment purposes (as opposed to medical purposes), e.g.
- Basic operations of arithmetic (e.g. mean, conversion of units)
- Plotting of results in function of time
- Comparison of the result to the limits of acceptance set by the user
This means that a basic remote patient monitoring system that does not provide any kind of decision support (such as automated analysis of ECG, or an expert system that highlights high-risk patients) is typically not a medical device, and is unlikely to be one even under MDR.
However, rumor has it that one aspect of the qualification guidance in MEDDEV 2.1/6 is likely to change. If a system is a medical device, under current guidance it is either a medical device or an IVD device depending on whether it contains an expert system that uses data coming from an IVD device. If yes, then the system is itself an IVD device:
This does not really make sense for remote patient monitoring systems, which are clearly not IVD devices even if some of the data they process comes from IVD devices – especially now that MDR has rules to handle such systems reasonably well, whereas IVDR does not.
The new version of the guidance is likely to change this so that a system is only qualified as an IVD device if the intended use of the system justifies it. So remote patient monitoring systems reading data from IVD devices are likely to be (more clearly) classified as medical devices under the new guidance.
Summary
In summary:
- If your remote patient monitoring system is not a medical device under MDD, it is likely not one under MDR either.
- If your system was a class I medical device under MDD, it is likely a class IIa or IIb medical device under MDR.
- If your system has an expert system that uses data from IVD devices, which makes it an IVD device under the current MEDDEV 2.1/6 guidance, it might be qualified as a medical device under the updated guidance.
Note that although being qualified as a medical device (rather than an IVD device) is in principle better for a remote patient monitoring system because the MDR is better suited for such systems, it does have the disadvantage that the IVDR date of application is May 26, 2022 whereas the MDR date of application is May 26, 2020. Thus, being qualified as an IVD device gives you two extra years before the compliance deadline.
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Disclaimer: Prediction is difficult, especially about the future. Your Mileage May Vary. All information in this blog post is for educational use only and should not be construed as legal advice.