Sweden is a lovely and industrious country that takes engineering very seriously; the small Scandinavian country that we know from its boxy but good cars also builds its own fighter jets (pretty good ones actually) and is determined to put its mark on the regulation of standalone software under EU medical devices law. The Swedish competent authority Läkemedelsverket has now issued a new version of the famous Swedish Document with the obvious agenda to influence guidance on standalone software under EU medical devices law in the way it has done before with MEDDEV 2.1/6.
Let’s take a look at the document, keeping in mind that the Swedish authorities tend to want to interpret the scope of ‘medical device’ with regard to standalone software wider than most EU countries. An indication of this is that on p. 17 it is stated that
“It is important to bear in mind that it is both the functionality of a product as well as the intended purpose stated by the manufacturer that determines whether software is qualified as a medical device.”
This is in contradiction with the case law of the European Court of Justice, which recently ruled in the Brain Products case that the intended purpose assigned to a device by the manufacturer determines its status as medical device, and not its functionality. Although the court was not as clear as it could have been – as I have argued – it held that using functionality as a deciding criterion would lead to regulation as medical devices of many devices that could be used as a medical device but are intended for other purposes, so this is the wrong way to interpret the concept of ‘medical device’.
This agenda of Swedish Authorities is pretty transparent when the report goes on to say that
“However, there are information systems for the health care sector where the manufacturer has not defined their device as a medical device, but still it could affect the safety for patients under certain conditions. Health care providers should in these instances still consider if those systems should be handled with the same awareness of safety as if it had been a medical device.”
“On the Swedish market most RIS are for instance CE marked as medical devices.”
In other words, we would actually like to regulate software of which the use in clinical settings could carry risk for patients, even though the report itself says that risk as such can never be a deciding criterion (p. 13). The report also doesn’t mention that the Swedish market is pretty unique in this respect and that this perspective is not shared by most other national authorities in the EU. I have it on good authority that there was also controversy about this between the member states when they were discussing the text for MEDDEV 2.1/6. Just so you know that this is clearly one view at one end of the regulatory spectrum.
As with the initial version the report provides a lot of useful detail and examples. Compared to the existing EU MEDDEV the report contains useful guidance on
- software as service (para 4.1.5), clarifying that this can of course also be a medical device;
- smartphone apps (para 4.1.6), clarifying that an app that qualifies as medical devices does not necessarily makes the phone as such or the combination of the two a medical device; and
- ‘home brew’ standalone software (para. 4.3), clarifying that one should approach this along the lines of the thinking surrounding home brew IVDs.
The appendix to the document is well worth reading and contains several separate annexes on interesting subjects with a lot of practical information and guidelines:
Annex 1. Risk management
Annex 2. Standards and recent development of standards
Annex 3. Clinical evaluation of medical information systems
Annex 4. Networks
Annex 5. Procurement and issues referring to CE marking (most interesting for me personally, as it discusses tendering strategy for software systems)
Annex 6. Product examples (the largest part of the document, with 19 case studies of software examples. Exercise with caution however, as the Swedish authorities tend to draw the scope of the concept ‘medical device’ wider than others).
All in all a very worthwhile read indeed and guaranteed to provoke discussion in the process surrounding the revision of the standalone software MEDDEV 2.1/6. Also, the annexes provide useful practical examples for the growing apps and other software industry about how conformity assessment for a software medical device works.
However, I think the report could have done better at discussion of the concept of accessory. The report stops at the statement that “[s]tandalone software can, without having a medical purpose of its own, be essential to maintain an intended function of another medical device. It can then be an accessory to a medical device.” This is not a very precise statement at all. I, personally, think that the definition of accessory is extremely important, as the discussion of several examples of modular systems in the report shows when it discusses how non-medical modules can still be regulated as accessories to the medical device module. I think it is even more crucial to develop a position on the concept of accessory in view of the considerable extension in scope in the current proposal for the new regulation on medical devices and the proposal for a new regulation for IVDs to include devices that not only “enable” but also “assist” a medical device in achieving its intended purpose. The definition of this humble little concept will have a severe impact on regulation of standalone software in networks and systems, and, consequently, all eHealth, telemedicine and mHealth services that rely on networks and systems.
Hi Eric, very nice sharing. But in Annex 6 of Swedish Document, they classify Video appointments as Telemedicine System and be Class I MD, this is conflict with the MEDDEV 2.1/6, what do you think about it?
Hi David, I think this is exactly what I cautioned for in my blog post: the Swedish authorities tend to interpret the concept of ‘medical devices’ more widely than it should be. I take it you refer to the video appointments example on p. 60 and the analysis on p. 61? I think the MPA’s analysis is not correct: they reason that every video appointment system is a telemedicine system and every telemedicine system has a medical purpose and therefore must be CE marked as medical device. This reasoning is clearly flawed as you correctly point out. If you apply the criteria in MEDDEV 2.1/6 it may be that a video appointment system has added medical device functionality, but that is not necessarily the case as the MPA assumes. If the functionality is limited to mere video communication like Skype or FaceTime it would normally not be a medical device. If you have any specific examples you would like me to look at I would be more than happy to do so.
Hi Eric, appreciate for your timely response. For me personally, video appointment doesn’t belong to MD, but in industry there are two opposite views on this issue. For example, Cisco announce their product “TelePresence VX Clinical Assistant” comply with MDD Directive and is a Medical Device, but Polycom announce their similar product “Practitioner Cart HDX” is just a communication solution, not a medical device. All the two products have similar function that enables secure and effective audio/ video communication between multiple healthcare providers and between providers and patients. For your reference, you can go to http://www.cisco.com/en/US/products/ps12152/index.html and “http://www.polycom.com/content/dam/polycom/www/documents/data-sheets/practitioner-cart-hdx-ds-enus.pdf”
Hi David, the law allows difference of opinion on the part of manufacturers and certification of devices as medical devices even if they are not medical devices per se. It can be a marketing point for companies (e.g. to be able to advertise something as ‘clinically validated’). Or it can be pre-emptive certification in view of additional functionality in the pipeline, or just because they want to be on the market in Sweden and the Swedish authorities require it. Lots of possible reasons.
Hi Eric, i just don’t agree with that “the law allows difference of opinion on the part of manufacturers and certification of devices as medical devices even if they are not medical devices per se. “.
Just now our company is developing a video appointment system that will be used to perform remote consultations between clinics and patients, we want to certificate the system as medical device, but when we asked EU NB（such as TUV PS,TUV Rheinland ext.）,they said the system doesn’t have a medical purpose and couldn’t be registered as medical device(as you know, Class I medical device shall be registered in EU Agency ), that is to say, not all the devices can be registered as Medical Device if they don’t have the medical purpose as prescribed in 93/42/EEC.
Hi David, if your company is developing a class I medical device, why ask a notified body about certification and registration matters? First, a notified body is only involved with class I devices if they have a measuring function or sterility (neither of which is likely to be the case for a video appointment system). There is nothing that prevents your company from self-certifying the system as class I medical device and notifying it to an authority in the EU for placing on the market. Secondly, authorities have the final word and not notified bodies. If your company would like the system to be a class I medical device, just register it as such in an EU member state that support this (like Sweden). Your device is then entitled to access to the entire EU market unless other authorities actively dispute that qualification. If you want my advice the details, let me know.
Hi Eric, Our company is a tradition IT company and doesn’t have much experience in Medical filed. We are not quite sure about if our product is a medical device or not. If YES, the equipment shall satisfy MDD Directive, if not, the equipment shall satisfy LVD Directive and EMC Directive. All these will affect our product design.
I know it’s the authorities that have the final word to judge if the device is a medical device or not, i mailed to MHRA of UK and BfArM of Germany for help, but there weren’t any response until now, that’s why I ask NB for assistance.
Following is our product description that I sent to NB: The System enables secure and effective audio/video communication between multiple healthcare providers and between providers and patients. The system transmits real-time audio and video captured by a high-definition camera and integrated microphone. It also receives real-time audio and video from a corresponding functionally like system in a remote location. Finally, the system supports transmission of real-time audio and video from peripheral audio/visual medical devices, which may be connected to standard audio and video inputs provided on the system, or patient’s historical static data such as electronic medical record/CT/image/medical examination report from Hospital workstation. The System is intended to facilitate remote provider/ patient and provider/provider consultations.
The opinion which NB gave is this product isn’t a medical equipment, but I think only the judgement from authority have legal validity.
By your convenience, would you mind helping us to clarify this issue (if the product belong to Medical Device or not)? Thank you very much.
Hi David, it would be my pleasure to help your company with this. Shall we continue the discussion by email? I have just sent you an email with my business contact details.
Thanks, Erik, for bringing this topic under the attention.
Although I’m not sure I agree this software to be classified as a medical device; I do agree with you advising David to register the product as a class I medical device in, for example, Sweden. In addition, I’d say: describe clearly why you think it should be classifiied as a medical device. For describing your product and its purpose I’d use the same structure as the MDD.
Something else struck my attention.
While the MEDDEV excludes software containing just communication and storage functionality, the Swedish competent authority reasons that such software qualifies as a medical device if it has a medical purpose. It has in the past repeatedly pointed out that there is no basis in the Medical Device Directive to rule out products on the basis of functionality. I.e. if a product has a medical purpose, it doesn’t matter what functions it contains: it qualifies as a medical device. The paper has now consequently taken step 3 completely out of their decision tree (flowchart p16). The cell phone examples on page 18 illustrate their position: software that just transfers information intended for medical use, qualifies as a medical device. One must acknowledge that this position is a very clear one, but more conservative than even the FDA position. The FDA includes Medical Device Data Systems (MDDS), i.e. systems that transmit data extracted from a medical device. The Swedes cast a wider net: also systems where the data is entered by a user qualifies if the system (read: the data) is intended for medical use.
Hi Koen, thanks for these observations. Food for thought!
Hi Koen, I agree with you, this clearly shows how the Swedish authorities interpret the scope of the concept of medical device far wider than most.