Welcome to Medical Devices: Domino’s Expert Corner, our new series looking at the latest industry news and insights from the world of medical devices, international regulations, and life sciences manufacturing.
In the first instalment of this blog series, our expert panel will focus on the upcoming European Union Medical Device Regulation and discuss some of the main challenges and opportunities for patients, healthcare providers, and medical device manufacturers.
Craig Stobie, Director of Global Sector Management
Bart Vansteenkiste, Global Life Sciences Sector Manager
Volker Watzke, EU Medical Devices Sector Manager
What is the European Union Medical Device Regulation?
From 26th May 2020, all medical devices sold in EU member states will need to include a UDI code, and be recorded in an EU database called EUDAMED, the European Databank for Medical Devices. With these regulations coming into effect, manufacturers now have a responsibility to invest in a solution that allows them to apply traceability codes onto a product as well as their packaging.
Fee payers and healthcare providers are obliged to refuse devices that do not reach the required standard. This means that all manufacturers, even outside of Europe, that want to sell their product into the European Union need to fulfil the requirements.
Medical device manufacturers will also be required to ensure that each product’s UDI code is registered in EUDAMED. Failure to comply may mean manufacturers will no longer be able to supply their products to other EU member states.
Having a database of all medical devices on the market is essential for patient safety.
Watzke: An article I read recently suggested that most authorities do not know how many medical devices are sold in their country. Germany, for example, does not know the number, and it could be anything in the range of 700,000 up to 1.5 million.
A connected world
The medical sector is in the middle of a transformation from manual data to digital data recording, which is accompanied by an increase in connected medical devices. A recent article by the Association for the Advancement of Medical Instrumentation, Software Implicated in Recall Spike, spoke about an increase in medical device recalls, due to issues with device software, prompting a discussion about potential issues with patient safety
Vansteenkiste: With these devices being connected, and connected in the Internet of Things, does this pose any extra risks? If I have a computer and I know you have a medical device, and it’s connected to the internet, and I want to do you some harm, potentially, I can try and get access to your medical device.
No doubt this is an issue to consider, but medical devices get smarter in the face of a high risk of manipulation, and great focus is placed on limiting the risk to the patient. Manipulation can cost lives, so there must be a major focus to secure those products.
Another interesting subject to consider is the role of connected medical devices and the protection of privacy in the EU. Are there any rules and restrictions regarding the data a device can contain about you and your medical risk or health insurance?
Watzke: Different countries have different data regulations. In some countries like Germany, it might be easier to access data, while other German-speaking countries might face stricter data regulation issues. The connection between a product and a patient can be quite difficult in some countries.
If the privacy laws are dictated by the country the device originates in, is this then going to cause complications for travellers who have connected medical devices? Does this cause a problem if a patient travels to another country on holiday and the data is not available?
Watzke: I think that the information should be recorded and saved and stored somewhere, on a chip card perhaps. It needs to be in the interest of the patient to make data available wherever he/she goes, to get the best access to medicines, healthcare, and doctors.
Access needs to be available, and privacy also needs to be respected. This adds a whole new dimension to the interoperability of medical device software and medical device connectivity.
Vansteenkiste: I think it will be good if the data is accessible from any hospital anywhere in the world. But, in terms of different legislations, I think that it could cause some problems if you are travelling across the world with all your data and people suddenly have access to your personal information.
The countdown is on
In similar sectors, we have seen industry bodies taking a leading role in advising members on new and upcoming regulations. For example, EMBO and Medicines for Europe have been very clear in their advice to their members. Is there a similar parallel in medical devices?
Watzke: There is one body, MedTech Europe, that’s the body for the medical device industry. However, because we have so many subsectors, it’s very challenging to get everyone together.
A recent article from Politico, The problem with EU’s new medical device rules, discusses some possible issues with the new EU MDR, including the strict 2020 deadline, and the need to reregister existing products. This is forcing manufacturers to make use of a grandfathering clause to put off certifying products and buy themselves more time to become compliant.
Stobie: The burden of the legislation raises the bar for many manufacturers. This is an avoidance scheme, and it’s not something that we want companies doing. Presently, we are seeing a huge demand for significant renewals under the existing regime.
Regulations Director, Oliver Bisazza, also warned of the potential discontinuation of many existing medical devices which have been relied upon for many years, brought on by the 2020 deadline.
Watzke: It will be a huge challenge to force a market with a majority of small and mid-sized enterprises and niche products to invest money to comply with the legislation.
This has the potential to prevent products from being available because of the new requirements and new legislation. A potential solution could be to move the deadline for compliance back for some products.
Watzke: We have already seen this in the US, where the deadline for Class I products has been postponed for two years, from 2018 to 2020.
Barriers to innovation
An impending deadline is not the only issue facing some manufacturers, with many start-ups left struggling to enter the market. This is due in large part to the absence of Notified Bodies – organisations certified by the EU to assess the conformity of certain products before being placed on the market.
BSI in the UK was the first Notified Body to be accepted, 17 months before the deadline. Fifty other Notified Bodies in the European Union still need to be certified. In the meantime three other notified bodies (TÜV Süd in June, Dekra IMQ in August) have been notified by the EU. From the original 57 Notified Bodies under the Medical Devices Directive and Active Implantable Medical Device Directive only 38 applied for accreditation according to the Medical Device Regulation and that number is decreasing.
With so few Notified Bodies to turn to for advice, it’s now very difficult to certify new products. Especially when you are a start-up, are not well known, and have not spoken to a Notified Body in the past.
Vansteenkiste: Again, this can also have an impact on existing products that are allowed in the European market. The deadline and the fact that manufacturers have to reregister all existing products could potentially lead to a lack of products in the market.
This is the case even when products have been available and widely used for the past few years.
Watzke: The legislation says that products that are already registered in line with the old directives are facing a transitional period. So, it’s possible that some products that are already in the market can last with their old certificates for another two to four years. A run to recertify the products according to the old directives has started to fall into the transitional period.
To add another level of complexity, different classes of products often have different requirements and different deadlines.
Vansteenkiste: As a manufacturer, you might have one set of products that is hit with the deadline and has a clear scope, and yet you might have another set of products that are very similar, that may not be due to be compliant for two, or three, or four years.
Add to this a lack of consistency within standards, and things get even more complex.
Watzke: Some products classified as Class III products, so products of high risk or critical risk to the patient, in the US might not be Class III in Europe. In addition, some products are not meant to be medical devices in the US, which are classed as medical devices in Europe. This is another challenge for manufacturers that have already applied and have been registered in the US.
In other sectors, we have seen industry bodies taking a leading role in advising their members on new regulations, however, this has not been the case in the medical devices sector, where it has proven difficult to bring together companies from different subsectors.
MedTech Europe, the body for the medical device industry, is currently limited in its membership only to very big companies, and a few European organisations.
A complex directive
Some of the biggest challenges of the EU MDR were outlined in a recent article from Med-Tech news, The top four challenges under the new EU MDR and IVDR, including issues surrounding reclassified and up-classified devices; elevated clinical testing requirements; increased demand on notified bodies; and the emphasis on post-market surveillance.
Our experts suggest that the four challenges that Med-Tech called out are very much administrative burdens and that the real issue is much more deep-rooted.
Stobie: One of the things that we see is several broader challenges: there is the issue of packaging real estate, fitness for purpose, and getting the identification code on all levels of packaging in the sterile environment. This is not a compliance project; it’s a fundamental behavioural change in business.
The whole production process now comes under the broader scope of this legislation. It’s not just a manufacturing process or a clinical trial process, it’s the whole product lifecycle.
Regulations like the EU MDR have a legal binding force in every member state and come into force on a set date, however, globally, there are differences, and even within a company, there are differences between the class of medical devices.
Stobie: Some parts are clear, some parts are still open to interpretation, and there needs to be a very, very clear view from each company what their compliance programme is going to be.
Manufacturers who distribute devices globally have an additional challenge, as they need to adhere not only to the new EU MDR but also to other global regulations. In the US, the database is called the Global UDI Database or GUDID. Every manufacturer that supplies a product to the EU and the US needs to register its product in the GUDID and EUDAMED separately – effectively doing the same work twice. It is likely that we will see separate databases in other countries in the future (China, Japan, India, etc.).
So, is there anything that manufacturers and companies can do to try and clear up some of this confusion?
With so much to consider, it is key for companies to engage with thought leaders, people who have a repository of knowledge on the medical devices sector, to get informed on this matter.
Stobie: You’ve got caregivers, you’ve got manufacturers, you’ve got healthcare providers, you’ve got people who are selling medical devices. There are also many medical devices used privately, in private clinics for non-urgent medical causes, which adds more complexity.
This puts more credence into making sure companies are talking to the right people who understand what’s going on. Manufacturers should speak to companies and people who have already gone through GUDID registration in the US for advice.
Notified Bodies can also be approached, but one thing causing further confusion here is that Notified Bodies currently benefit from verifying products. Manufacturers are therefore able to approach multiple Notified Bodies – if a medical device is not accepted, they can move on to the next one.
Watzke: That needs to be discussed again. In my opinion, there should only be one Notified Body set up for certain markets or products. Competition between the Notified Bodies will have a negative impact on patients’ health.
If you are still looking for advice on what the EU MDR legislation means and how it can affect your business, please get in touch. Our expert panel has a complete and thorough understanding of the EU MDR and is here to provide help and advice on how to become compliant as quickly and efficiently as possible.
Thanks for reading our first instalment of Medical Devices: Domino’s Expert Corner. Over the coming months, remember to look out for more blog posts, answering industry questions, and talking to experts across the world to help you in your medical device journey.