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Understanding the
MDR & IVDR:

What Medical Device Companies
Need to Know.

Two big deadlines are looming for manufacturers
who do business in Europe:

IVDR

In Vitro Diagnostics Regulation (IVDR), which takes effect on May 26, 2022

MDR

Medical Device Regulation (MDR), which takes effect on May 26, 2020
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These regulations are intended to place a greater emphasis on safety, with greater requirements for clinical evidence and increased oversight by regulatory agencies.

The regulations will not allow grandfathering of previously approved products, so device manufacturers will need to re-evaluate their entire product portfolio to identify the steps needed to ensure compliance. This impacts every aspect of the organization, from research and development to manufacturing and marketing.

Medical device manufacturers will likely need additional clinical data to certify and re-certify devices, which could be gathered or generated from various sources and methods. They will also need to perform additional post-market surveillance to provide safety and effectiveness oversight for the lifecycle of a device.

There are many understandable concerns about how this will impact device companies, and there are still many unknowns. In this resource, we’ll discuss the most important elements you need to know and how you can start preparing.

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Why MDR and IVDR
Compliance Matters

The history of clinical research includes numerous examples of device manufacturing that failed to protect patients.

Two examples in recent history illustrate this:

Toxic Hip Replacements

In the past two decades, there have been thousands of lawsuits related to metal-on-metal hip replacements from at least seven major medical device manufacturers. These devices were cleared through the FDA’s 501(k) program, which allows medical device manufacturers to earn approval of devices determined to be “substantially equivalent” to existing ones without conducting new research on human subjects.

When the metal-on-metal devices rubbed against each other, they released toxic particles that caused serious side effects, including memory loss, the formation of necrotic tissue and allergic reactions.

These devices were found to cause significant harm to many patients, resulting in numerous lawsuits.

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The PIP Breast Implant
Scandal

The Poly Implant Prothese (PIP) Breast Implant Scandal is another example of a large-scale failure to protect patients.

To save money, Jean-Claude Mas, a former butcher turned medical sales representative, began using breast implants from a cheaper, industrial-grade silicone that was not approved for medical use.  These inferior implants ruptured at a rate that was double the industry average, causing inflammation, scarring and potential long-term side effects.

“The PIP scandal made it clear that immediate improvements in the oversight of medical devices were needed,” the European Commission stated in a 2014 news release. More ongoing clinical evidence and transparency may work to rebuild physician and patient trust in a system that is in place to safeguard consumers of medical devices.

“One of the key objectives of the new MDR is to ensure a consistently high level of health and safety protection for EU citizens using these products,” said Dr. Norbert Clemens in another European Commission news release.

What Are the
MDR Requirements?

The MDR replaces the Active Implantable Medical Device Directive (AIMDD) and the Medical Device Directive (MDD), the current regulations in place for medical devices in Europe. The new regulations have a wider scope, requiring data-based evidence for both new and existing medical devices.

Here are the key elements all medical device manufacturers need to know.

1

Devices Are
Covered Under MDR

The new regulations now apply to all devices and services sold in Europe. Some products are excluded. Others that combine a medical device and an in-vitro diagnostic device follow specific rules.
2

Risk Management Systems

Under MDR, medical device manufacturers must have risk management systems and quality management systems in place.
3

Post-Market Surveillance

Manufacturers must continue collecting sufficient clinical evidence for all devices once they are on the market, provide documentation and apply a conformity assessment procedure that demonstrates the continued safety and effectiveness of the device.
4

New Data Reporting Requirements

The MDR requires manufacturers to report data collected on their devices using a new centralized electronic system known as EUDAMED, which is required to register clinical trials. This data will be made publicly available, with the goal of increasing transparency. 
5

Risk Classes
for Devices

Medical device manufacturers are responsible for determining which devices will be reclassified according to MDR and which will need further review by a notified body.
6

Liability for
Defective Devices

Manufacturers must have systems in place to cover their financial responsibility for harm caused by defective devices. Every manufacturer must also have a named person responsible for regulatory compliance.
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What Are the
IVDR Requirements?

The new In vitro Diagnostic Regulation (IVDR) replaces the EU IVD Directive, which has been in place in Europe since 1998. This new regulation, intended to improve the health and safety of in vitro diagnostic devices, went into effect in April 2017. Device manufacturers must be fully compliant with this regulation by 2022.

The main elements are similar to the MDR, with a few added elements:
Where previously approximately 10% of IVDs required clinical data for approval, now an estimated 90% of devices will now be required to have supporting clinical data for approval under the IVDR.

What All Medical Device Manufacturers Should Do Now

With these deadlines looming, medical device manufacturers should take steps to prepare, starting with evaluating their product portfolio.

Manufacturers will need to conduct a cost/ROI analysis to determine what new data they will need. Here’s a helpful framework for moving forward:

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Consider: Do You Need
Additional Data?

  • Are you making new marketing claims for an existing product?
  • Is there data available in the current standard of care use available to collect that would support new claims?
  • What makes business sense to pursue approvals under MDR/IVDR?
  • What will be allowed to run out the clock, and become obsolete?
  • Will approval/re-approval be initially sought under MDD or MDR/IVDR?
  • What capabilities are available in-house?
  • What does a needs assessment reveal?

Strategize

Once you have determined you’ll need additional data to support your device, you’ll need to develop a plan for obtaining it.

Conducting a full-blown clinical trial is costly and time-consuming, but it may be necessary. You might also be able to use existing data from previous studies and sources.

The support you’ll need from a contract research organization (CRO) will depend on the study design you choose. You may need full-service study management or just one specific service, such as monitoring, auditing, training, consulting, safety oversight or remote data collection and data entry. 

Other data collection design options include:

  • A retrospective study
  • A prospective study
  • A placebo/comparator-controlled study
  • Post-market clinical follow-up
  • Literature review
  • Registry data
  • Other Real World Evidence sources
Execute

Execute

Enlisting a trusted contract research organization (CRO) will help you conduct compliant studies that protect human subjects, data integrity and your investment of resources. A CRO can also assist with post-marketing clinical follow-up (PMCF) plans.

Use creative approaches to plan strategic protocols, leverage real-world evidence (RWE), use electronic medical records for remote data collection and entry, and implement remote monitoring approaches to efficiently collect critical data.

Leverage Data

Post-market surveillance is an important part of the new MDR and IVR requirements. Data collected in support of increased clinical evidence needs may aid in identifying product improvements, labeling updates and additional indications to explore.
Utilize a global approach to integrate processes developed in support of MDR/IVDR to support innovation, improve human health, build trust in patient populations, and compete in an evolving global landscape.
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How IMARC Can Help You Comply

There’s no way around it: complying with these new regulations is going to be painful. But the pain is lessened when you have a trusted advisor who will walk you through it.

As a global full-service medical device CRO, IMARC has 20 years of experience helping manufacturers achieve compliance. We can support your team through this transition in a number of ways, including:

  • Conducting a full-blown clinical trial
  • Developing your strategy for retrospective data collection
  • Collecting real-world evidence
  • Choosing and implementing a robust data management system
  • Developing or improving a quality management system
  • Providing remote research coordination and site support for retrospective data collection

To Learn More About How We Can Help:

Download our whitepaper &
view our recent webinar. Or contact us today about your EU MDR strategy.

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