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Preparing for the EU Medical Device Regulation

Despite a delay to the EU MDR, there are many changes for medical device manufacturers to put in motion now. Can freelance scientists help?

The EU Parliament has adopted the EU Commission’s proposal to postpone enforcement of the EU Medical Devices Regulation (MDR) by one year until May 2021. The decision to delay was made in response to the COVID-19 outbreak’s impact on manufacturers, notified bodies, suppliers, research institutions, and other parties, with patient health and safety as a guiding principle. Though this delay would give businesses an extra year, it will be challenging for some businesses to prepare in the context of the pandemic. (The proposal does need to be approved by EU member states and published in the Official Journal before it will enter into force, but this is expected by May 26, the EU Parliament reports.)

The shift from the previous regulations, the Medical Devices Directive (MDD), to the MDR (officially titled Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices), will bring significant changes and a more stringent requirement to obtain the much-needed CE mark. The impact will be felt by every medical device manufacturer in the EU―and those that sell into the EU―because it will apply to existing products, not just new entries to the market.

Kolabtree has had many enquiries from medical device manufacturers who need help from a freelance scientist, whether it’s with adjusting to changes to traceability, device classification, or post-market surveillance. Commonly though, we find businesses are looking for a medical writer to help with their technical documentation, which we’ll come on to later. Some common enquiries relating to the changing regulations are explained below.

Classification Changes

Under both the MDR and the MDD, medical devices are categorized into four classes: I, IIa, IIb, and III, with the classification relating to the degree of risk associated with a device. The new regulations mean that some products will fall into a different group than they did before.

“The fact that certain products will be moved into a different class is likely to cause difficulties, particularly if a product will be moved to a higher class,” explains Kolabtree freelancer Dr. Sergio Perez. “The change of class will affect other areas of the regulation and, if the device is moved into a higher class, will come with more stringent requirements.

“For example, the manufacturer may need to provide additional data on an existing medical device if a device moves from Class IIa to III, where a clinical investigation is needed to justify certain clinical claims,” he adds.

Another cause for concern may be for companies whose products were not previously classified as medical devices at all. Liposuction equipment and contact lens solution, for example, will be covered under the MDR, so manufacturers of such products will need to catch up quickly with MDR requirements.


Under the MDR, you can meet the safety and performance requirements using either clinical data from your own device or an equivalent device. The purpose of claiming equivalence is to avoid having to conduct redundant studies. One reason this may be challenging is that the MDD did not define equivalence, while the MDR has a clear statement on what it is.

Under the MDR, it will be more difficult than it used to be to claim equivalence. According to the definition, you must prove that a product is biologically, technically, and clinically equivalent to the reference product, and it may be difficult to come across this degree of information on a competitor’s product.

If a company is no longer able to claim equivalence with a product that they previously could under the MDD, they may be required to perform further research or remove a claim from their product.

Many manufacturers of devices that have been on the market for years will have to determine whether they have enough clinical data to comply with the MDR. This will prompt them to take steps such as conducting their own post-market clinical follow up studies and other post-market surveillance activities.

Clinical Evaluation Reports (CERs)

A clinical evaluation report (CER) is part of the technical file that provides information on the device design, features, intended use, risks, data sources, and more. Producing CERs involves multiple stages: defining the scope of the device, collecting and validating clinical data, analyzing and interpreting the data, competitor and equivalence analysis, and identifying risks and uncertainties during post-market surveillance. This is an ongoing process, which should be updated throughout a device’s lifecycle.

The MDR will increase the emphasis on CERs, requiring an increased level of knowledge, understanding, and expertise. This stepped-up level of understanding combined with the significant amount of changes from the previous regulations will make CERs into a stumbling block for companies transitioning to the new regulations.

“Identifying and gathering all the data that goes into the CER and preparing the document according to the guidelines can take several weeks or months,” explained Kolabtree freelancer Dr. Sophie Laurenson. “Post-market surveillance (PMS) forms a big part of the process even after CE Mark certification, and PMS has to be a core part of the manufacturer’s quality management system (QMS). Some cases also require post-market clinical follow up (PMCF) which involves proactive collection of clinical data and evaluation to meet safety and performance requirements.

“The CER is not a static document. It is recommended that medical device manufacturers develop a robust process and strategy incorporating good practices to help them retain market access in the EU, avoid any product recalls and streamline their time and resources used to maintain the document,” she added.

Because of such challenges, numerous companies are hiring a freelance clinical evaluation report writer. When looking for a CER writer, it is important to look for a qualified expert with experience in clinical research methodology across a range of therapeutic areas. They should also be experienced in regulatory affairs and well versed in scientific literature, added Kolabtree freelancer Mahasweta Pal.

Adapting to all the changes in the MDR can seem overwhelming for many medical device manufacturers. While the original deadline has been extended by a year, manufacturers still need to prepare themselves so that they can obtain that much-needed CE mark in time for May 2021.



Six million more to benefit as NHS locks in the benefits of stronger partnerships

The NHS and its partners will be able to ‘lock in’ improvements to their work by putting whole-system planning at the heart of coronavirus recovery plans, the NHS’s Chief Operating Officer said today.

The comments came as NHS England and NHS Improvement confirmed four new ‘integrated care systems’, together serving more than six million residents.

As part of the effort to respond to the COVID-19 health emergency, NHS and local government staff have been fast-tracking new technology, new partnerships and new ways of working, to make services easier and more convenient for residents.

Integrated care systems (ICSs) and, in other areas, sustainability and transformation partnerships have been central to the coordination and delivery of this response, bringing together hospitals, care homes, GPs and others to plan for immediate and future needs. This has included important initiatives between NHS and local government, such as mutual aid agreements.

A further four ICSs were confirmed today, joining 14 previously announced plus two devolved health systems in Greater Manchester and Surrey. Taken together, around half of England’s population is now served by such a system.

This includes the whole of Yorkshire (with the confirmation of an ICS covering Humber, Coast and Vale) and all of London south of the river Thames (with South West London joining its neighbour in South East London).

The two other partnerships confirmed today are one covering Sussex, and another in Hertfordshire and West Essex.

Highlights of recent partnership work in these areas include:

  • Hospitals in Hertfordshire and West Essex are working together to build a vascular services network built around a specialist centre with vascular hub sites elsewhere. This will improve diagnosis, care quality, experience and outcomes for patients such as those who require major arterial surgery.
  • Humber, Coast and Vale has developed new roles in its health and care workforce to support existing doctors, nurses and therapists and meet local need. This has included helping to train and recruit more than 300 advanced clinical practitioners, nursing associates and physician associates, who are already enabling more people to access faster care and support.
  • The NHS in South West London has joined forces with 140 schools and 6 further education colleges to improve mental health support for around 80,000 pupils. The programme offers group and one-to-one work with pupils, online resources, staff training and parent workshops.
  • The system covering Sussex improved performance against the national A&E four-hour target by 1.2 per cent during 2018-19 (compared to a small dip elsewhere) while improving its financial position more (at 2.4 per cent) than any other part of country.

Amanda Pritchard, Chief Operating Officer at NHS England, said: “The response to COVID-19 has touched every part of our health and care systems. We have seen our hospitals transformed, accelerated use of technology in GP surgeries, mental health services and hospital clinics, innovation in community-based services and been reminded of our interdependence with social care, and the critical role of public health. The response to the COVID-19 health emergency has been whole-system working and so must be the recovery.

“As well as locking in the improvements we want to keep, we must maintain the agility that has served the NHS so well. Changes that have been debated for years, delivered overnight with strong partnership working. We have acted our way to transformation and better care, and we must continue to do so.”

To become an ICS, each system has shown that its partners have a shared vision to improve services for its whole population now and in future, backed up by robust planning and strong collective leadership and accountability.

In areas not yet designated as integrated care systems, whole-system efforts have been overseen by sustainability and transformation partnerships, which perform a similar local leadership role while they prepare to make the transition to full ICS status by 2021, as set out in the NHS Long Term Plan.

ICSs bring together local organisations in a pragmatic and practical way to deliver the ‘triple integration’ of primary and specialist care, physical and mental health services, and health with social care. They will have a key role in working with local authorities at ‘place’ level, and through ICSs, commissioners will make shared decisions with providers on population health, service redesign and NHS Long Term Plan implementation.



Continuous glucose monitoring market surge during Covid-19 pandemic

The continuous glucose monitoring (CGM) devices market is set to grow robustly regardless of the major upheaval caused by the Covid-19 pandemic. According to GlobalData’s analysis, the global CGM market was valued at $3.3bn in 2019 prior to the pandemic. GlobalData expects CGM market growth to reach mid-double digits in 2020.

The major three players in the industry, Dexcom, Abbott and Medtronic, reported promising Q1 data for their CGM products. Dexcom’s revenue in Q1 grew 44% versus the same quarter of 2019 to $405.1m, while Abbott reported more than $600m for FreeStyle Libre with an increase of 62.5% versus Q1 2019. Medtronic said supplies and consumables in its Diabetes Group are in high demand, while the vast majority of Medtronic’s businesses have experienced declines.

Additionally, Dexcom’s G6 received regulatory approvals in Australia, Japan and South Korea. Abbott’s FreeStyle Libre expanded its reimbursement coverage in Japan to include people with type 2 diabetes who inject insulin multiple times daily. Therefore, the glucose monitoring market in Asia-Pacific is likely to expand exponentially in 2020.

During the Covid-19 pandemic, there has been an emphasis on the use of virtual clinics and telemedicine for diabetic management. For example, the UK’s National Health Service (NHS) updated its clinical guide to encourage remote contacts via telephone, email and video conferencing. This has resulted in an increased demand for diabetic care devices that can share data remotely.

There are significantly more data available by using CGM devices, which can help patients and healthcare providers improve glycemic control and potentially increase patient self-management. Covid-19 has opened new opportunities for the CGM systems to gain more popularity in the diabetic care market.

The surging demand for CGM is primarily driven by a growing awareness of the devices but also partly due to companies’ quick responses to the Covid-19 pandemic. Both Dexcom and Abbott have received clearance by the US Food and Drug Administration (FDA) to make their CGM systems available for use in hospital settings and other healthcare facilities. Health Canada recently announced that the Dexcom G6 CGM system has been temporarily authorised for expanded use in Canadian hospitals.

Remote monitoring with CGM devices for patients with diabetes can help reduce exposure for healthcare providers and preserve personal protective equipment. Additionally, similar to insulin giants Novo Nordisk and Eli Lilly, CGM companies have initialised new patient assistance programmes to support current CGM customers who have lost insurance due to the Covid-19 pandemic in the US. Dexcom reduced its CGM cost to $45 per 90-day supply for its existing, qualified patients.

However, the CGM startup company Senseonics has been severely hit by Covid-19. Unlike other CGM devices, the sensors used in its Eversense CGMs require in-clinic procedures that have decreased greatly due to the outbreak. The company suspended its sales and marketing efforts to acquire new users of CGM to reduce commercial costs. As a result, the current top players in the CGM market are expected to strengthen their leadership in 2020.




FDA Authorizes First COVID-19 Test Using Saliva Collected at Home

FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples. The test remains prescription only.

To be clear, this isn’t the first test the agency has authorised with a home-collection option, but it is the first saliva-based COVID-19 test with a home-collection option. Rutgers’ test previously had been added to FDA’s high-complexity molecular-based LDT “umbrella” emergency use authorisation to permit testing of samples self-collected by patients at home using the Spectrum Solutions SDNA-1000 saliva collection device.

Last month FDA authorised the first diagnostic test with a home-collection option, but that test uses a sample collected from the patient’s nose with a nasal swab and saline. That authorization is for LabCorp’s COVID-19 RT-PCR test using samples patients collect themselves with LabCorp’s Pixel home collection kit.

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“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen Hahn, MD. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”



Pulmonx raises $66m to commercialize minimally-invasive emphysema treatment

Pulmonx announced today that it raised $66 million in a financing round led by global life science investor Ally Bridge Group.

The Redwood City, Calif.-based company also received contributions from new investors Adage Capital Management, HealthQuest Capital, Partner Fund Management and Rock Springs Capital, along with existing investors. Pulmonx secured an additional $17 million in growth capital through CIBC Innovation Banking for refinancing an existing debt facility.

Pulmonx said in a news release that the proceeds from the funding are earmarked for the global commercial expansion efforts for the Zephyr Valve system for severe emphysema, a form of chronic obstructive pulmonary disease (COPD).

The Zephyr Valve system is an FDA-approved minimally invasive treatment option. Its treatment is performed through a bronchoscopy with no incision or tissue resection.

“We are pleased to be able to accelerate our efforts to bring our landmark technology to severe emphysema patients who need it,” Pulmonx CEO Glen French said in the release. “The recently secured financing will ensure we are able to continue to scale our commercialization efforts to meet the global demand for our Zephyr Valve system, as well as continue R&D efforts on new minimally-invasive pulmonary treatments.”



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