The EU Medical Device Regulation

Dive Brief:

• The trade association representing the medical technology industry in Europe is calling for comprehensive structural reform to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) framework to prevent delays in treatment for patients.
• MedTech Europe, in an open letter to EU Commissioner for Health and Food Safety Stella Kyriakides, said on Friday the MDR and IVDR regulations have not fully achieved their intended objectives, despite more than six years of implementation. The letter was also signed by 34 national trade groups.
• “Delayed access may become a reality as the latest state-of-the-art prevention, screening, treatment, and care services will not be available at the speed that some patients might need,” the trade groups said in their letter.

Dive Insight:

The EU Council earlier this year provided more time for notified bodies that certify medical devices in Europe to comply with the regulatory overhaul, pushing deadlines out to 2027 and 2028 amid a backlog of recertification requests. Companies that operate in the European market previously were expected to have devices recertified by May 2024 under the new regulatory framework, but concerns about potential shortages of medical devices in the EU prompted the European Commission in March to extend the timeline.

The medical device groups, in Friday’s letter, said the European Commission and Medical Device Coordination Group have done “considerable work” to address short-term implementation challenges. Nonetheless, they said, “there are structural issues in the regulations which cannot be solved simply through their implementation. The regulatory framework is unpredictable, complex, slow and costly.

“The result is that medical technologies – both those already on the market and future innovations − struggle to reach European patients and health systems.”

Changes are needed to make the CE marking system more efficient and reduce the administrative burden under the new regulations, the groups argued.

The letter also called for the inclusion of an “innovation principle” that “swiftly connects the latest medical technologies to European patients and health systems through dedicated assessment pathways and early dialogues with developers.”

The groups proposed the establishment of a single, dedicated structure to oversee the regulatory system, including the designation and oversight of notified bodies.

“It is of paramount importance that we ensure that medical technologies continue to reach patients and health systems in a timely manner,” the trade groups wrote.

When the EU Council in March granted notified bodies in Europe more time to process a backlog of recertification requests under the legal overhaul known as the Medical Device Regulation, relief – and questions about compliance requirements – followed. Noting that more than 500,000 certifications must be completed, trade group MedTech Europe said the added time – with deadlines pushed out to 2027 and 2028 – will accelerate efforts to bring new devices in the pipeline to patients. But the group cautioned that clear pathways are still needed to prevent orphan and niche devices from “disappearing” from the market.

U.S. trade group AdvaMed said more clarity is needed on processes for submitting applications to notified bodies and demonstrating certificate extensions, but welcomed the extended timeline.

Life sciences attorney Erik Vollebregt, a founding partner of Axon Lawyers in Amsterdam who has been navigating the MDR’s complexities for more than a decade, spoke with MedTech Dive about what happens next.

This interview has been edited for ease of reading.

How will the additional time to implement the MDR affect companies?

VOLLEBREGT: We will also see what unintended effects the proposal has. For example, as a result of the removal of the sell-off period, it is possible that certain legacy devices may be sold off for decades. These will be hard to still recognize as compliant devices at some point. In addition, since notified bodies will have more than four years in a lot of cases to complete conformity assessment. It will be interesting how they will prioritize the processing of all the applications that they receive just before May 26, 2024. It may mean that some manufacturers could theoretically be waiting for their MDR CE mark for over four years.

Does the extension give notified bodies enough time to complete their work?

VOLLEBREGT: Whether the proposal does what it is intended to do will also crucially depend on the MDCG (Medical Device Coordination Group) and member states’ roll-out of the 19-point plan in MDCG 2022-14 that is intended to free up capacity at notified (bodies) and stimulate faster processing of applications. I am not hopeful on this. The first reaction of the Dutch minister of health to adoption of the amendment was that manufacturers should now ensure that their devices are MDR-certified as quickly as possible. This completely misses the point of how the proposal works, because once the manufacturer has made his application before May 26, 2024, it is up to the notified body to process the application as quickly as possible. This is where the authorities come in, but given this reaction, the authorities (at least the ones in the Netherlands) apparently do not see themselves to be part of the solution, which is disappointing. 

[A spokesperson for Dutch Health Minister Ernst Kuipers responded in an email to MedTech Dive: The Minister of Health of the Netherlands is of the opinion that a smooth transition to the MDR/IVDR can only be achieved when all parties take their responsibility. By supporting and actively contributing to the creation of the MDCG 2022-14 and the amendment of the transitional provisions, the Minister has shown that he is aware of the importance of the efforts of authorities and notified bodies in this process. With that, the Dutch authorities are actively monitoring the implementation of the MDR/IVDR and are in close contact with all relevant stakeholders.]

What comes next?

VOLLEBREGT: The Commission is in the process of collecting information from stakeholders and experts about the functioning of the MDR, and the EMA (European Medicines Agency) is slowly but surely scooping up more and more regulatory functions under the MDR and IVDR. If this amendment does not fully live up to expectations, I predict that a pretty radical revision of the EU medical devices approval system may be in the stars in the midterm future.

[The] next things to watch for are the rollout of guidance from the Commission and the MDCG and the notified body administrative annexes to expired certificates to be able to prove that they are nevertheless valid. Also we will need to see how the MDCG and the member states will be part of the solution in rolling out the 19-point plan in the MDCG 2022-14 position paper to free up capacity of notified bodies and allow them to function more efficiently.

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By: Seth J. Goldenberg, Ph.D., VP, Vault Medical Device & Diagnostics

Across the globe, medical device regulators are introducing significant changes to the processes by which device and diagnostic products come to market. Aimed at improving patient safety, these developments emphasize more robust clinical data, reassessment of risk classification, improved traceability, and stringent pre-market quality and post-market surveillance procedures.

To meet these challenges, manufacturers must significantly adapt their business processes to focus on efficient management of information and communication throughout their organizations and the broader marketplace.  Add in unexpected situations like COVID-19, and it becomes even more challenging for regulatory teams.  Companies face finding ways to rapidly register vital products for diagnosis and treatment, and without a single source of data and virtual collaboration, it is not possible.

The application of the European Union Medical Device Regulation (MDR) means that device manufacturers face a rapidly-approaching deadline to adapt to a drastically more stringent regulatory environment in Europe. The grace period for certificates issued under the old Medical Device Directive (MDD) incentivized device manufacturers to focus their efforts over the past three years in getting products to market before the cutoff. Given the recent extension of the initial MDR deadline, manufacturers should seize the opportunity to revisit their MDR compliance plans, rather than bringing products to market under MDD.¹

In the US, a revitalized FDA is reorganizing its medical device arm, the Center for Devices and Radiological Health (CDRH).² Modifying its longstanding structure around the product lifecycle stage, CDRH is forming new teams by therapeutic area to facilitate efficient information sharing. CDRH's transformation serves as a call to device manufacturers to re-evaluate structures and processes. The future demands a new approach to data management and communication.   

Beyond the EU and the US, regulators are not standing still. Countries representing major markets for global device manufacturers are paying close attention to their colleagues at higher-profile agencies and taking initiatives to update their regulatory frameworks.

Historically, information within device companies has been siloed with a host of aging and incompatible IT systems dividing each functional area.  Across departments, variations of the same processes were repeated in different ways, causing duplication and inefficiencies. In the new landscape, where regulators track a product throughout its lifecycle, this model does not suffice.   

While the regulatory burden on global device and diagnostic manufacturers is increasing, these changes present a unique opportunity to discover new efficiencies and foster collaboration across functional areas within and beyond the organization's four walls. Forced by regulatory mandates to adapt, the C-suite will be willing to invest in new data harmonization models and information sharing that ease the burden of compliance and increase efficiency across the organization.

The same technologies that enable regulators to be more targeted with their resources can be used by industry to meet these new demands. Cloud applications, explicitly built for device manufacturers, mean that the fabled single source of truth can become a reality.  This single source of truth has far-reaching implications not only for regulatory, but also for R&D, clinical, quality, medical, and commercial functions.

The Council of the EU voted in March on an extension of deadlines for complying with Europe’s Medical Device Regulation (MDR), in a move to keep critical treatments on the market during the transition period.

The revised timeline gives notified bodies that certify devices in the European Union longer to prepare for the new regulatory framework.

Companies that operate in the European market were expected to have devices recertified by May 2024 under the regulation, but with the deadline approaching, notified bodies faced a backlog, prompting the European Commission to propose extending the time frame.

The industry welcomed the amendments when they were introduced, “they are the culmination of many warning signs about a potential shortage of medical devices in the EU,” Brussels-based life sciences lawyer Josefine Sommer, a partner at Sidley Austin, wrote in an email.

The extension staggers deadlines until 2027 or 2028, based on device risk classification, allowing manufacturers and notified bodies more time to complete conformity assessments. Products placed on the market under the predecessor Medical Devices Directive (MDD) could remain, under certain conditions.

“Once the amendments have been adopted, it will be interesting to see how the conditions for benefiting from the additional transitional periods are to be interpreted and implemented in practice,” Sommer said.

The European Council vote in March followed the European Parliament’s approval the prior month of the new timetable. EU procedure called for both branches of the legislature to approve the plan. 

“This will be the final step in the process,” an EU official said in an email.

Member state health ministers in the EU’s Employment, Social Policy, Health and Consumer Affairs Council backed the plan in December, after European medical societies called for urgent action to address device supply shortages reported by physicians.

“The Health Council supported the European Commission’s proposal to delay the transitional deadlines to avoid causing harm to EU health systems and, most critically, patient care,” London-based attorney Lincoln Tsang, partner and head of Ropes & Gray’s European life sciences practice, wrote in an email.

The MDR was adopted in 2017 following the recalls of breast implants and metal hip replacements due to safety problems. The regulation tightens controls for the safety and performance of medical devices and includes stricter monitoring and certification procedures to ensure compliance and traceability. The new rules also are intended to reflect technological and scientific advancements in the sector.

With the extended deadlines, higher-risk devices such as implants must transition to the new requirements by December 2027, and medium- to lower-risk devices such as syringes or reusable surgical instruments have until December 2028.

But Erik Vollebregt, a founding partner of Axon Lawyers in Amsterdam, said the timeline still requires manufacturers to be MDR-ready, “with an MDR application in the door at a notified body” no later than May 26, 2024.

“The current state of the market is that everybody is still figuring out what the proposal will mean for them specifically, both industry and notified bodies. Some manufacturers have seen 2027 and 2028 as dates and do not understand that these are dates for notified bodies and not for manufacturers,” Vollebregt said in an email.

Reuters reported in December that medical device manufacturers were dropping products from their European portfolios because of the cost of complying with the new regulations.

Although six new notified bodies received MDR designation in the second half of last year, it created a pool of 36 organizations to process around 23,000 certificates of current devices on the market, prompting EU Health Commissioner Stella Kyriakides to propose delaying enforcement of the MDR.

Medtech trade group AdvaMed welcomed the EU Council’s decision in March to approve a longer transition period for the Medical Device Regulation (MDR) but said the industry still faces challenges in adapting to the new rules.

As anticipated, the Council adopted legislationto extend the deadline for certifying medical devices in Europe, a move prompted by concerns that bottlenecks in the process to date could cause supply shortages.

“Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access,” Acko Ankarberg Johansson, Swedish minister for healthcare, said in a statement.

Medical device makers now have until Dec. 31, 2027 for higher-risk devices and Dec. 31, 2028 for medium- and lower-risk devices to be recertified for use in the EU’s 27 member states. However, only devices for which manufacturers have already started the certification procedure will benefit from the additional time, the Council said.

The newly adopted measures also aim to reduce the risk of shortages by removing the so-called “sell-off date” rule that called for the withdrawal of devices already on the market but not yet with the final user. Only products that comply with previous EU medical device laws can remain on the market longer, the Council said.

AdvaMed CEO Scott Whitaker called the timeline extension for certifying devices under the MDR’s more stringent conformity assessment system a “strong step forward” for patients worldwide, but cautioned that challenges in the transition to the new rules continue.

“We’re working to fully address several remaining issues, including a clearer process for submitting applications to notified bodies, as well as greater clarity on how certificate extensions can be demonstrated. We are also working to address practical implementation issues, such as access to ‘orphan’ and niche devices in the EU market,” Whitaker said in a statement.

The medtech industry trade group is coordinating with European association MedTech Europe to address the concerns, he added.

The Council and European Parliament adopted the MDR in 2017, and companies that operate in the European market were expected to have completed the transition by May 2024, but a backlog of devices awaiting recertification and a shortage of approved certification organizations, known as notified bodies, prompted the European Commission to propose extending the time frame. The Parliament approved the new timetable last month.

“The EU is one of the world’s preeminent markets for quality patient care, R&D, and access, serving millions of patients annually, so it’s critical that MDR implementation is done correctly,” said Whitaker. “AdvaMed will continue to champion a robust EU regulatory scheme that fosters innovation and patient access to treatment in a timely and predictable manner.”

New medical device regulations in Europe could result in a shortage of medical devices for children, the European Academy of Paediatrics and more than 20 other medical associations wrote in a June 27 letter to European Commissioner for Health and Food Safety Stella Kyriakides.

Reports available to clinicians indicate a “high likelihood of losing significant numbers of essential medical devices,” the groups wrote. “This will result in an avoidable risk of death and serious injury, not as a consequence of unsafe medical devices, but as a consequence of disappearance of devices due to unforeseen effects of the EU MDR.”

The cost of certification by notified bodies poses a barrier to manufacturers of devices that cater to small groups of patients, such as children or people with rare diseases, and could result in manufacturers withdrawing devices sold in smaller numbers from the EU market, they wrote.

European regulators voted earlier this year to extend the transition period for the Medical Devices Regulation (MDR) to 2027 or 2028, depending on a device’s risk category. 

However, the deadline for submitting devices to certification organizations, known as notified bodies, is much sooner. Manufacturers need to submit applications to a notified body by May 2024 and have a contract in place by September 2024 to be able to market their devices. 

The cost of this process “forms a critical financial barrier for manufacturers” to introduce, or re-introduce, devices in the EU market, the medical associations warned in a letter. For example, one company with a single device received invoices of 800,000 Euros for a conformity assessment, which would allow it to be on the market for five years, they wrote. By comparison, 510(k) clearance in the U.S. costs roughly 5,000 Euros. 

Some types of devices are already facing shortages, the letter writers warned. Balloons used to treat certain congenital heart defects in newborn infants have become unavailable, and shortages have been reported for dialysis machines used to treat young children with end-stage kidney disease. 

The groups suggested establishing an EU-wide system to monitor whether specific medical devices are about to disappear from the market and creating a status designation for “pediatric” or “orphan” devices that could result in faster and cheaper conformity assessments. 

In the interim, the associations recommended automatically granting permission for continued use of high-risk pediatric or orphan medical devices that have been on the market for at least three years without reported problems.

MedTech Europe set out its vision for cybersecurity in the medical technology ecosystem in a paper that argues for industry-specific legislation.

The trade group outlines three areas of discussion, starting with its belief that medtech security should be regulated under sectoral legislation such as the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

Other parts of the paper address MedTech Europe’s preferred approach for tackling ransomware and support for actions to improve digital literacy in general and cybersecurity skills in particular.

More connected medical devices have increased the risk that hackers will access confidential data or gain the ability to modify technologies in ways that put patients at risk. As the risks increase, medical device manufacturers “continue to invest significant resources in guaranteeing state of the art cybersecurity for all their products and services,” the trade group wrote.

Other groups including legislators and regulators also play a role in protecting devices and data. The position paper covers how the groups can work together, calling for a multi-stakeholder approach to ransomware, and investment in education and training in cybersecurity.

MedTech Europe argues that MDR and IVDR “should remain the primary avenue to providing state of the art cybersecurity of digital medical technologies and services.” The paper goes on to explain that the medtech industry itself “has an integral role to play in creating a more resilient shared healthcare ecosystem.”

The trade group’s case for continuing to rely on MDR and IVDR rests on the claim that the regulations “wholly account for cybersecurity throughout a medical device’s lifecycle.” Given that the regulations “lay out comprehensive, essential requirements for digital medical technologies and services” and the Medical Devices Coordination Group has provided guidance, MedTech Europe sees sectoral legislation as sufficient. 

Some European Union legislation already covers multiple industries and MedTech Europe supports those existing initiatives. For example, the trade group said the latest version of the Network and Information Security directive provides a basis for “manufacturers to comprehend and implement the range of cybersecurity and data protection requirements across the entirety of a medical device’s lifecycle.”

Dive Brief:

• The U.K. medtech regulator shared a roadmap of the documents it will publish to create a new framework for the sector over the next two years. 
• In the roadmap, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) sets out plans to talk to the medtech industry about its approach to unique device identification, quality management systems (QMS), implants and more.
• The MHRA plans to have the “core elements” of the new framework for medical devices in place by the next year. The regulations are intended to support more international harmonization.

Dive Insight:

Delays to the European Union’s new device regulations meant that framework never became part of U.K. law. As such, the U.K. left the EU with device regulations that dated back to 2002 and the freedom to set its own rules for the industry going forward. The government established a transitional period that runs to 2028 or 2030, depending on the device, to avoid supply disruption while it moves to the new framework.

The first item on the roadmap for 2024 and 2025 is a discussion about international recognition. The MHRA began talking to industry participants last year and has received some positive feedback. Peter Ellingworth, chief executive of the Association of British HealthTech Industries, said in a statement that “international recognition will ensure that U.K. patients maintain access to safe and effective health tech, that is both life-enhancing, and life-saving.”

The MHRA said the international recognition framework will enable “swifter access” to devices that are already approved by “comparable regulators” or have Medical Device Single Audit Program certificates. The outline of the framework is in line with MHRA’s international recognition procedure for medicines, which offers shorter reviews of drugs approved in seven countries and regions including the U.S. and EU.

Over the rest of 2024, MHRA plans to hold talks about topics such as scope and classification, essential requirements, approved bodies, clinical investigations, QMS and conformity assessments. The MHRA shared more details in another document, explaining that it plans to change the classification of several types of devices and bring essential requirements into closer alignment with the EU rules. 

Implantable medical devices are an area of focus. MHRA plans to classify implants as part of changes that “will result in more stringent pre and post market requirements and requiring manufacturers to provide implant cards to enable patients to know which device they have had implanted.” Implants have been a focus for the government since a report it commissioned found fault with oversight of the devices in 2020.

Great Britain is set to extend its acceptance of CE-marked medical devices for up to seven more years to avoid Brexit-related disruption.

The current law prohibits manufacturers from placing CE-marked medical devices on the market in Great Britain from July onward. However, the government plans to introduce legislation that will allow CE marks to be used in the region until 2028 or 2030, depending on the device.

Officials proposed the new timelines to ensure medical devices remain available in Great Britain while they work to set up a new post-Brexit medtech regulatory regime.

England, Scotland and Wales, collectively known as Great Britain, never adopted the European Union’s Medical Devices Regulation (MDR) because its delayed date of application happened after the end of the Brexit transition period. Northern Ireland, which along with Great Britain makes up the United Kingdom, is subject to MDR under the terms of the Brexit deal.

As such, Great Britain needs its own regulatory regime for medical devices and in vitro diagnostics (IVDs). The government outlined its plans in 2022, at which time it was targeting a 2023 implementation date for the new regulations. Officials extended the transitional arrangements out to July 2024.  

The new plan gives the industry even more time to adapt. Officials are now aiming for “core aspects” of the future regime for medical devices to apply from July 1, 2025. Manufacturers will still be able to sell CE-marked devices in Great Britain for years after that date.

Under legislation that the government plans to introduce soon, CE-marked “general medical devices” that comply with the outgoing EU directives can be sold in Great Britain until June 30, 2028. The transition period for IVDs placed on the market under the outgoing directive, and for all medical devices that comply with MDR, will end on June 30, 2030.

The transition period applies to CE marks granted before Great Britain fully establishes its own medtech regulatory regime in July 2025, according to a statement issued by the Medicines & Healthcare products Regulatory Agency.

Manufacturers with CE marks that expire after that date will need to get certified under the new Great Britain system. The agency said it plans to adopt new, stronger postmarketing requirements in mid-2024.