Medical Device Regulation (MDR) is postponed until 2021

The new European Union regulations for medical devices will now come into full force on May 26th 2021. Which will be music to the hears for many medical device manufacturers considering a lot of Notified Bodies were struggling to cope with the increase in demand to help companies transition to the new regulations, which were due to come into full effect in May 2020. In fact, some of them were no longer accepting new applications for ISO 13485 certification, as they did not have the resources available.

Transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) has kept the med tech and pharma sectors extremely busy over the last couple of years. The MDR introduces some significant changes to the way in which medical devices, especially medical device software and apps can be legally marketed within Europe and this has created some considerable challenges for some of the smaller, more entrepreneurial driven companies.

So why the delay? Basically COVID-19 is behind it all. The EU wanted to ensure that there would be no delays in getting new devices like respirators onto the market to help prevent shortages of life-saving equipment in hospitals that are treating patients with Coronavirus.

What are the key changes?

The new Medical Device Regulation (MDR) and the related In-Vitro Diagnostics Regulation (IVDR) was introduced in 2017 and organisations were allowed this 3-year period to be able to transition and comply with these new regulations. The MDR replaces the previous MDD and one of main areas it has impacted is in the development of medical apps and eHealth software.

As a results of the new rules and criteria that have been incorporated into the MDR many medical app developers will now be facing a situation whereby their app is not compliant. We’ve seen rapid growth in the number of health and medical apps that have been developed and launched on the app stores over the last 5 years. Unfortunately, the Competent Authorities in each country (like the MHRA in the UK) who are responsible for ensuring that any medical device that is placed on the market is safe to use were late to catch-up with the boom that has taken place in the medical app development sector. This has meant that many of these health and medical apps that have been placed on the app stores prior to the launch of the MDR will now be classed as medical device software (MDSW) and the developers will now need to obtain the proper certification in order to keep marketing those products legally to customers.

Article 19 of the MDR states:

It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software’s location or the type of interconnection between the software and a device.

 Furthermore, those manufacturers that have their devices already CE Marked (under the MDD) may find that the classification of their device has changed under the MDR. Many Class I devices will now be upgraded to a Class IIa device and this change will significantly impact many smaller manufacturers and mHealth start-ups. This is because if your device is Class I then in most cases you won’t need to have a conformity assessment carried out by a Notified Body, you can do a self-assessment. As the legal manufacturer of the medical device software / app  it is your responsibility to demonstrate that the medical device meets the requirements in the MDR or IVDR by carrying out a conformity assessment. The assessment route depends on the classification of the device, so that is the first thing you will need to do.

To summarise the top-line process for bringing a medical device software or app to market would typically be as follows:

  1. Classify your device (i.e. Class I, Class IIa, Class IIb, Class III etc)
  2. Pass a conformity assessment
    (Self-assessment for Class I medical devices and Notified Body approval is required for Class IIa upwards)
  3. Draw up a declaration of conformity (Annex IV of the MDR and IVDR)
  4. Place a CE mark on the device
  5. Assign a Basic UDI-DI and provide it to the UDI database.
  6. Submit key information about the manufacturer, and authorised representative and importer if applicable, to the electronic system (Eudamed).
  7. Place your CE marked device anywhere in Europe or put your device into service

Closing thoughts

As I have pointed out the changes that are going to be introduced in May 2021 will impact some manufacturers more than others, mainly smaller mHealth start-ups and mobile app developers. This is because adherence to the various harmonised quality and data protection standards are going to dictate that those businesses re-design their software development, risk and quality management processes in order to comply with the MDR. This will not only take time to implement but will also incur additional costs through obtaining the correct certifications and involving Notified Bodies as part of the conformity process. Finding the right app or software developer and compliance experts to work alongside you to help you to create all the appropriate documentation is going to be key but be warned these specialist businesses are already stretched and their high demand has driven up the price of their services so it may be more economical for you to invest in and develop these skills in-house.  Our medical & health app developer directory could act as a useful starting point to help you find suitably skilled app developers and compliance experts that you can bring on board as part of your medical device software development team.

Avoiding app store rejection – the importance of using a medical app development specialist

There are many risks associated with using an app development agency that doesn’t specialise in developing medical apps but the most common one is app store rejection. Read on.

Over the past few years the gApps team have heard stories of a number of eHealth entrepreneurs and healthcare companies that have embarked on an app development project with a generalist digital agency only to find out that at the end of the development process they’ve have been unable to get their newly developed medical app published onto the app store.

This is because more often than not the main reason why their app has been rejected is because it does not conform to the regulatory guidelines that have been set for publishing medical apps. If you’re developing an app that is going to be classed as a medical device, then Apple will need to see evidence that you’ve compiled the appropriate paperwork required for launching an app of that nature onto the market. This will often include a genuine copy of the CE Mark certificate that only gets issued to the manufacturer of the device once all the required paperwork has been submitted to the appropriate competent authority within your country, like the MHRA in the UK.

Apple released their expanded section focused on safety requirements for health and medical apps back in 2016, so we get a little surprised when we get requests for help from companies who have had their app rejected due to regulatory issues.

Under the “Physical Harm” section, the guidelines provide several examples of user risk issues that may lead to rejection of an app.

  • For instance, medical apps intended for diagnosis or treatment or that run the risk of generating inaccurate health data “may” undergo more vigorous review by Apple; apps that have received regulatory clearance should provide links to appropriate documentation, as well
  • If your medical app has received regulatory clearance, please submit a link to that documentation with your app.
  • Drug dosage calculators must come from the drug manufacturer, a hospital, university, health insurance company, pharmacy or other approved entity, or receive approval by the FDA or one of its international counterparts. Given the potential harm to patients, we need to be sure that the app will be supported and updated over the long term.

If you’re looking to develop a medical device app then it’s vital that you do the required regulatory research and due-diligence on the app development companies that are being considered for your project. Ask them to show you apps that they have developed which carry the CE Mark (all apps that are classed as medical devices need to have a page within the app itself where the CE Mark is displayed).

You’ll need to consider the classification of your device as the guidelines differ for the various regulatory classes as well as the software safety class, while making sure your organisation can meet all of those guidelines. Also don’t forget that as of May 2021 your app all will need to conform to the Medical Device Regulation MDR.

At the end of the day the guidelines are there to protect patients and healthcare professionals that will be using your app and if you or your chosen app developer doesn’t have the required expertise to not only code these types of apps but to also produce the appropriate compliance paperwork for submission, then you will end up facing the same scenario above, which could prove very costly.

If your app meets the definition of a medical device then you could also face a significant fine for a regulatory violation, from the competent authority responsible for the registration of medical devices. Developing mobile applications that function as medical devices is complex. Choosing the right partner is more than just about assessing their technical capability. Medical device app developers also need to understand the regulatory and data security requirements, so make sure you do the right research before choosing your app development partner.

Useful resources

We have created a number of useful resources which will help you to better understand what additional aspects of app development you’ll need to consider if you’re developing an app that will be classed as a medical device:

How the Internet of Things (IoT) is transforming healthcare

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It is predicted that by 2024, mobile technology and the Internet of Things (IoT) will have transformed medical provision and healthcare management, all over the globe, beyond recognition.

Imagine a shirt that detects variations in blood sugar levels, contact lenses that can monitor changes in the retina or a toilet that can record hydration levels or vitamin intakes in the user. As Sci-Fi as this sounds, all these could be part of every day life in 10 years time.

Medical care provider Bupa have said that all kinds of ‘connected’ apps from those in household appliances to ones in furniture will all be supporting our daily health in ten years time. The mHealth app of tomorrow will monitor health and alert the user to any danger and may also incentivise healthy life style choices by offering rewards through ‘gamification.’ It is thought this would be done in much the same way as games like Foursquare, or Angry Birds unlock badges as rewards. Such an approach and the use of IoT technology and mobile health apps in this way is predicted to have a major role to play in preventing disease and dramatically reducing the onset of ever increasing complaints like diabetes.

Dr Paul Zollinger-Read, Chief Medical Officer at Bupa was reported as saying that mobile technology and advancements in the connected home (thanks to the Internet of Things) “gave us a glimpse into the future and allows us to imagine a time where people can become guardians of their own health,” he said, adding that “being aware of their likelihood of disease and possible risk factors, coupled with constant monitoring through intelligent technology means that they will be able to spot the symptoms of illness from a very early stage, or simply prevent them altogether.”

Some of the innovations that Bupa have suggested that might become part of our everyday life include ‘smart nappies’ that allow parents to monitor a range of things from hydration to kidney infection in babies. Moving away from the device accessed mHealth app, the fabric of clothes may become a monitor of pulse and heart rate while sensors in shoes will monitor periods of inactivity and prompt the wearer to exercise. One of the first forays into the world of tomorrow is perhaps the recently developed smart contact lens that can detect glucose levels in patients with diabetes through monitoring their tears. And in 2016 human trials of a miniature artificial pancreas will began.

There is no doubt that the advent of IoT technologies and connected mHealth apps are the spring board to a future where we will be able to monitor our health on a minute to minute basis and only visit the doctor when the apps monitoring our health tell us that we need to.

10 Tips for Launching a Health App

The buzz surrounding health apps is quickly becoming a deafening roar and that first comer window of opportunity is closing fast. While there is no doubt that health apps are the way of the future, as an avalanche of them become available, here are ten tips to help make your mHealth strategy and mobile app a success.

1. Originality – Present your app as offering something original that actually makes a useful contribution. Or if your app is in a category that already exists present your app in a unique new and attention getting way.

2. Strategy – Nothing is likely to be much of a success without the right amount of planning. Plan your strategy in a systematic way. Look at the app from the customer’s point of view. If you were they, would you buy it? Check that you are within compliance requirements and whether or not your app needs to be registered as a class 1 device.

3. Website – First A great website is half the battle of marketing your app. Make sure that yours is professional looking and up and running, without glitches, before you launch. Tell people how your mHealth app will benefit them and make your website a great marketing tool. Also don’t forget to optimise it for relevant key phrases so that people can find it on search engines like Google.

4. Social Media – Your mHealth app will stand the best chance if it is fully supported by social media. Twitter is an excellent platform that will supply you with endless attention free of charge. However with a 140-character limit make sure you choose your words wisely! Other social media platforms like LinkedIn and Facebook are also key networks that will give you a channel to get people talking about your app. Also don’t forget the much smaller, niche social networks that also exist within your sector, sometimes you will find that these can be more effective in terms of engaging and interacting with your target audience.

5. Sales Pitch – Make sure that you have honed your sales pitch to the best that it can be before you do anything else. Your sales pitch needs to convince people to take the next step. Creating app promo videos are often a great way to show people the key features and benefits of your app.

6. Blogs – are very popular and setting up a good one can be a great step towards your having a successful mHealth app. They are very much joined at the hip with social media and if you can get Tech sites or other relevant sites to feature you, then that will also be an invaluable l marketing tool. Also reach out to other influential bloggers and ask if they’d be interested in writing a post about it.

7. The Friendly Approach – Make your tweets, posts and blogs casual, and not too formal, but still professional. People respond better to a more friendly approach.

8. Tease! – Start the hype early and keep the customer guessing as you build up to the launch. Make the eventual reveal an event that people want to know about.

9. Media Hype – Creating a buzz or media hype around your mHealth app will certainly help it launch. Offer free downloadable press releases of your app with high-resolution images for potential users. Ask reputable, category specific blogs to feature any promos.

10. The Big Launch – All the hype and the work you have done towards launching your mHealth app will be wasted if your launch ends up as something of a damp squib. Ensuring that you have maximum app store visibility is key so you amy also want to consider an app store optimisation (ASO) campaign. Make sure that you send out newsletters and press invitations – do everything you can to make the launch go with a bang.

If you are considering developing a health or medical app then check out our resources section or use our directory to find a suitable medical and health app developer.

Tips for designing a medical app – is connectivity on your list?

One of of the gApps team came across an interesting discussion on LinkedIn titled: “One tip for designing a medical device.”
Members of one of the medical device groups were being asked to share their views on what advice they would give someone when it came to designing a medical device?

The post as you can imagine got a great deal of response (the group currently has over 320,000 members). I read through the responses with interest and although all the responses were well considered. Some of the advice shared was:

“I would recommend co-development of the product with the customer. This provides clear understanding by both parties of what the design requirements are, what testing is required, expected costs, lead times, design for manufacturability issues, and mostly, you have the most important thing, at least one customer.”
“In my past we were successful by starting a voice of customer assessment and convert that into a list of customer requirements. Then have R&D translate that into functional spec of what they could provide and on top of that what other features or capabilities that customers are not aware of. Then a negotiation occurs where there are mismatches and confirmed with customers. In parallel how will it be verified and validated, sample availability, collaborations needed? Then and only then do we start development.
“Ask the customer exactly what they need and why, what are the features they could not do without? Would this new product get then to move away from what they already use, and why, why not? ensure they get just that… and quickly. Then ensure their experience is backed up with service.”

“Most of the time customers, don’t really know very clearly what their needs are, especially physicians. But patients, caregivers probably understand better way what can help them and what they are willing to pay for it. Latin America still needs help in rural medicine: handle chronic disease, early diagnosis especially in oncology. I agree about co-development.

As you can expect with any conversation around new product development there is this recurring theme of start with the end-user. And this is all sound advice and as a marketer this notion that the customers’ needs drive the NPD process is etched into my brain. But it also got me thinking that when it comes to medical devices we should also be considering how we can take advantage of new technological advances taking place and look for opportunities to future-proof any device that we are looking to design. This will help to increase the product’s shelf-life as well as improve the product’s chances of generating a healthy return on investment. But as we know technology is moving faster than ever so this becomes and an even greater challenge for medical device manufacturers.

One area that can sometimes get missed during the initial concept and business analysis phases is “connectivity” – so assessing the capacity for the interconnection of platforms, systems, and applications. We would most certainly be bringing connectivity to the table early on in the process and exploring how mobile technologies could help to improve the user experience and also the cost effectiveness of developing such a device.

Here are some examples of companies that have benefited from developing medical device apps and apps that connect with existing hardware devices:

Improving end-user experience

  1. Control interfaces: OvuSense streamlines the user experience taking advantage of high res screens with more real estate to graphically monitor temperatures and get fertility predictions compared the original black and white LCD screen on the original hardware product http://www.ovusense.com/uk/
  2. Portability and access: Rosemont Pharma changed a very large ring bound folder which references their entire product range and has consolidated all the information into an online database which is updated to an app every time the app is opened and fits in the pocket. The app also included a dosage calculator (CE Marked) to make it easy for HCPs to calculate the dosage requirements based on key factors: https://www.rosemontpharma.com/prg/
  3. On Demand: Dr Now / Push Doctor, these types of on demand apps are the future of medical services. Real time access to medical professionals when required with minimum disruption to your own schedule. http://www.drnow.com/ http://www.pushdoctor.co.uk/
  4. Data sharing and analysis: Diabetes apps like enable patients to accurately monitor their blood sugar levels and at the same time automatically share this data with healthcare professionals who can monitor their patients remotely and intervene if necessary. http://www.mystarsanofi.com/web/products/glucometers/ibgstar

Cost of development

  1. Less investment in hardware: Fertility Focus have moved away from the physical production of a hardware reader to an app that utilises the hardware within a device. This massively reduces the investment in manufacturing and enable a constant evolution of the product features http://www.ovusense.com/uk/
  2. Concept testing / rapid prototyping: The Instant Weight For Height calculator was prototyped and tested by healthcare professionals to make sure it was easy to use and complex calculations would be simple to interpret before going to the coding stage. This allowed for a much quicker development cycle having ironed out any design issues before hand
  3. Updating firmware: Fitbit is a good example of where the product software or firmware is constantly evolving to incorporate customer feedback and improve user experience. Distribution is over the air via an app update which in turn updates the firmware on the wrist band. http://www.fitbit.com
  4. Distribution: The distribution and update of apps has become a seamless process with both Apple and Android devices performing automatic updates for the apps running on their devices. This massively improves reliability of the apps, the devices and is a simple push to an app store that then distributes the apps to millions of devices. http://www.apple.com http://www.android.com