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Author: Anne Holland, CEO and Founder

As we move into 2022, we decided to take a step back and look at the year ahead.

What should we prepare for? What potential issues lay in front of us? How can we help our clients overcome these challenges?

Unsurprisingly, COVID-19 has continued to force the industry to adapt to the persistent roadblocks it’s created. We also anticipate some uncertainty surrounding FDA inspections, increased cybersecurity concerns, and two new regulatory frameworks coming from the EU.

Here’s some insight into the five medical device industry issues on our radar for 2022.

Issue #1: FDA Inspection Uncertainty

What’s the likelihood of the FDA paying your facility a visit in 2022? According to an analysis from The National Law Review, it’s uncertain.

Their analysis found that inspections were most common in areas where registered firms were most prevalent, making your location a huge factor in your chances of having an inspection.

However, locations of FDA district offices or regions don’t seem to play a role in areas where inspections are most prevalent. All in all, their findings show that it seems there are only county-level hotspots and not necessarily state or regional hotspots.

This can cause medical device companies some level of anxiety, however, the proper guidance and preparation can set you up for a smooth FDA inspection process.

Issue #2: Increased Cybersecurity Concerns

Medical device manufacturers should stay vigilant and prepare for potential cybersecurity attacks during 2022. The increased use of digital health technologies over the past two years, primarily due to the COVID-19 pandemic, has made the medical device industry a growing target for cybersecurity hackers.

Improper management or mitigation of cybersecurity risks for devices could ultimately lead to decreased availability and functionality of devices, delays in treatment or surgeries, or even worse, illness or death.

This concern has reached the FDA as they’re set to release new draft guidances in 2022 pertaining to these growing security issues entitled:

  • Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
  • Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
  • Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
Issue #3: Continued Supply Chain Challenges

The ongoing COVID-19 pandemic and its negative effect on the supply chain have impacted how nearly every industry obtains, manufactures, and distributes their products—the medical device industry is no different.

For example, when COVID-19 rates are high, hospitals have reduced or even eliminated elective surgeries. Additionally, some hospitals have significantly reduced their product inventories. Thus, the demand for single-use instruments and other devices has decreased.

With the advent of the vaccine, elective surgeries have begun to come back again. However, this increase in demand has left manufacturers scrambling. In response, many suppliers have increased their prices.

We anticipate the waxing and waning of COVID-19 rates paired with an unstable and unpredictable global supply chain to continue to present challenges to medical device companies in 2022.

Issue #4: Implications of the EUDAMED Launch

While initially slated to go live in 2020 at the same time as the Medical Device Regulation (EU) 2017/745 (MDR)’s date of application, the ​​European Database on Medical Devices (EUDAMED) is expected to launch by no later than May 2022.

The Commission of the European Union (EU)’s intention for this database is improved transparency and coordination of information about all medical devices approved under the MDR.

Once the EUDAMED goes live, companies will need to register their device(s) and ensure they meet all relevant requirements if they haven’t done so already.

Issue #5: Preparing for IVDR

A new regulatory framework, In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), is set to replace the current Directive 98/79/EC on in vitro diagnostic medical devices on May 26, 2022.

IVDR will create a new regulatory framework for any in vitro diagnostic medical devices. Examples include:

  • HIV tests
  • Pregnancy tests
  • SARS-CoV-2 tests

This will create significant changes to the sector, such as increasing the involvement of independent conformity assessment bodies (‘notified bodies’) and a set of common rules for in-house devices.

Lean Into Our Medical Device Industry Expertise

Our wide breadth of medical device industry knowledge allows us to steer our clients through any potential issues that may present themselves.

Whether you need help with an FDA inspection, risk management, medical device regulatory affairs consulting, or an EU MDR regulatory strategy, we do it all.

Let’s get the quality conversation started.